Elective Surgical ProceduresPhase 4NCT04894864

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

A Phase 4 study testing Opioid-Based Anesthesia-Analgesia Strategy and Opioid-free Anesthesia-Analgesia Strategy in people with Elective Surgical Procedures and Postoperative Pain, run by University of Crete at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Elective Surgical Procedures, Postoperative Pain, Anesthesia
What is being tested?: Opioid-Based Anesthesia-Analgesia Strategy and Opioid-free Anesthesia-Analgesia Strategy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteGreece
Study dates: 8 Oct 2020to 1 Sep 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient Consent
Age between 40 and 85 years old
Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair

Who cannot join

Immunocompromised patients
Patients with active infection
Reoperation on the aorta
Inflammatory bowel Disease
Malignancy
Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis)
Chronic corticosteroid or immunosuppressive drug use
Intraoperative transfusion with >2 units of packed Red Blood Cells

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

George Papastratigakis, MD contact

00306979056672

papastratigakisg@gmail.com

Georgios Stefanakis, MD contact

00306978779726

G_Stefanakis@yahoo.com

Greece1 site, 1 recruiting

University of Crete
Heraklion, Crete, 71110
George Papastratigakis, MD, 00306979056672, papastratigakisg@gmail.com
Recruiting

Other trials in Greece

About this study

Official title: Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects.

Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

Read the detailed description

Open abdominal aortic aneurysm (AAA) repair surgery is a high-risk operation, often performed on high-risk patients. Despite advancements made in diagnosis, management, surgical techniques and treatment of these patients, morbidity and mortality remain high. Mortality after open AAA repair remains higher than the average mortality of the matched population for age and sex. Debate is ongoing as to whether open AAA repair or endovascular aneurysm repair (EVAR) is better in terms of overall long-term survival rate.

Regarding open AAA repair, the very nature of the surgery itself, with surgical trauma, aortic cross clamping and its resulting ischemia-reperfusion injury, and cellular interactions of blood with the biomaterial surface of the graft, causes intense and varied metabolic, endocrine and immunological responses. These surgical stress-related responses are evident as marked increases in inflammatory cytokines such as TNF-a, IL-1a, IL-6, IL-8, IL-10, stimulation of the sympathetic system, and stimulation of the hypothalamic-pituitary-adrenal axis, caused by release of CRH and AVP. High levels of IL-6, peaking at 4-48h after clamp removal, have been associated with serious postoperative complications and its levels reflect the intensity of surgical trauma following AAA repair. Other inflammation markers such as CRP and leukocytes have also been shown to increase postoperatively.

While the surgical technique has been extensively studied as to the role it plays on the control of the surgical stress response, patient outcome, morbidity and overall mortality, fewer studies have been conducted to study the effect of the anesthetic management on these factors. While most of them have been focusing on the comparison of general anesthetic vs regional techniques, only few compare different general anesthetic techniques on patient outcome.

Modern general anesthetic techniques have been revised and rely on a multimodal anesthetic and analgesic perioperative regimen for improved patient outcome. A multimodal regimen requires the administration of at least 2 factors with different mechanisms of action. At least one factor causes inhibition of central sensitization and at least another one inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli, mitigating adverse neuroplasticity. One such example, is an Opioid-Free Anesthetic-Analgesic (OFA-A) strategy, which implements a variety of pharmacological agents, including some with demonstrated immunomodulating and anti-inflammatory effects. Apart from sparing any opioid-related adverse effects, an OFA-A multimodal strategy targets optimal analgesia with a multitude of factors in the lowest possible dose, aiming for additive or synergistic effects. An additional advantage of using an OFA-A technique is the prevention of opioid-induced hyperalgesia.

Our hypothesis is that implementation of a multimodal OFA-A strategy, leads to a decreased sympathetic and inflammatory response, compared to conventional opioid-based anesthetic techniques. A decreased inflammatory and stress response as expressed by reduced levels of IL-6, IL-8, IL-10, TNF-a, CRP, cortisol, arginine vasopressin (AVP), white blood cells count and hemodynamic stability is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.

Conditions: Elective Surgical Procedures, Postoperative Pain, Anesthesia, Opioid Use, Abdominal Aortic Aneurysm Without Rupture, Vascular Surgical Procedure
Being tested: Opioid-Based Anesthesia-Analgesia Strategy, Opioid-free Anesthesia-Analgesia Strategy
Keywords: Opioid-free Anesthesia-Analgesia, Cytokines, Opioid-based Anesthesia-Analgesia, Haemodynamic Stability, Open Abdominal Aortic Aneurysm Repair, Immunomodulation, Inflammatory Markers
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opioid-Based Anesthesia-Analgesia StrategyDrug
Also called Opioid-Based Anesthesia, OBA-A
A perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.
Opioid-free Anesthesia-Analgesia StrategyDrug
Also called Opioid-Free Anesthesia, OFA-A
A perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.

Study groups in NCT04894864
Study group	Role	What they receive
Opioid-Based Anesthesia Analgesia	Active comparator	Premedication: IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Propofol 2-3mg/kg, Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg. Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg/kg, Fentanyl 1-2mcg/kg during induction and 50-100mcg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. ICU stay sedation: Remifentanil infusion, until removal of the endotracheal tube. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g x3 +/- Dexketoprofen trometamol 50mg x2. Rescue therapy only: Tramadol 50-100mg. Receives: Drug: Opioid-Based Anesthesia-Analgesia Strategy
Opioid-Free Anesthesia Analgesia	Active comparator	Premedication: Pregabalin 50-150mg x2, IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Dexdmedetomidine 0.5-1mcg/kg, Lidocaine 1mg/kg, Propofol 2-3mg/kg, Ketamine 1-1.5mg/kg, Hyoscine 10mg, Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg, Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg. Anesthesia maintenance: Desflurane set at ~1 MAC, Dexmedetomidine 0.2-1.2mcg/kg/h, Lidocaine 0.5-1mg/kg/h, Ketamine 0.3-0.5mg/kg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. ICU sedation: Dexmedetomidine + Lidocaine infusions, until removal of the ETT. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os x1 and 25mg x1, up to x2, Paracetamol 1g x3 +/- Dexketoprofen trometamol 50mg x2. Rescue therapy only: Tramadol 50-100mg. Receives: Drug: Opioid-free Anesthesia-Analgesia Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical Stress Response - IL-6 - Preoperatively
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - IL-8 - Preoperatively
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - IL-10 - Preoperatively
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - Copeptin - Preoperatively
Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - Copeptin - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - Copeptin - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - Copeptin - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - TNF-a - Preoperatively
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - Cortisol - Preoperatively
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - CRP - Preoperatively
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - WBC - Preoperatively
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Measured: 1) Preoperatively (as a baseline)
Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Measured: 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Measured: 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Measured: 4) 24 hours after aortic cross-clamp release
Haemodynamic Stability - Tachycardia
Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in as a percentage of the total surgical time in which the participant exhibited tachycardia.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Bradycardia
Intraoperative Bradycardia (defined as PR≤ 40 bpm), with episodes lasting ≥1 minute. Data will be reported in as a percentage of the total surgical time in which the participant exhibited bradycardia.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Hypotension SBP
Intraoperative Hypotension (defined as SBP≤90mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypotension, based on the SBP values.
Measured: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Hypotension MBP
Intraoperative Hypotension (defined as MBP≤65mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative MBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute MPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypotension, based on the MBP values.
Measured: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Hypertension
Intraoperative Hypertension (defined as SBP ≥120% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypertension, based on the SBP values.
Measured: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements averaged over the total surgical time. Data will be reported in ml/kg*h.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements. Data will be reported in ml/kg*h.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements averaged over the total surgical time. Data will be reported in ml/kg*h.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements. Data will be reported in ml/kg*h.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Blood Loss - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Blood Loss - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid Balance - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance averaged over the total surgical time. Data will be reported in ml/kg/h
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid Balance - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance. Data will be reported in ml.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged rate in mcg/kg*min.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements.Data will be reported as an averaged rate in mcg/kg*min.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged rate in mcg/kg*min.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged rate in mcg/kg*min.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged rate in mcg/kg*min.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

Secondary outcomes (71)

Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 1) Immediately postoperatively (if awakened prior to ICU admission)
Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 2) First postoperative day
Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 3) Second postoperative day
Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 4) Third postoperative day
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
Measured: 1) Immediately postoperatively (if awakened prior to ICU admission)
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
Measured: 2) First postoperative day
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
Measured: 3) Second postoperative day
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
Measured: 4) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Intolerable" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Intolerable" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Intolerable" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Tolerable with discomfort" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Tolerable with discomfort" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Tolerable with discomfort" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Comfortably manageable" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Comfortably manageable" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Comfortably manageable" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Negligible Pain" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Negligible Pain" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
1. Intolerable
2. Tolerable with discomfort
3. Comfortably manageable
4. Negligible Pain
The percentage of patients that report pain that is "Negligible Pain" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "Getting worse" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "Getting worse" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "Getting worse" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "About the same" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "About the same" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "About the same" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "Getting better" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "Getting better" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
1. Getting worse
2. About the same
3. Getting better
The percentage of patients that report pain that is "Getting better" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients that report "Inadequate pain control" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients that report "Inadequate pain control" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients that report "Inadequate pain control" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients that report pain control that is "Effective, just about right" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients that report pain control that is "Effective, just about right" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients that report pain control that is "Effective, just about right" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
1. Inadequate pain control
2. Effective, just about right
3. Would like to reduce medication
The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
1. Can't do anything because of pain
2. Pain keeps me from doing most of what I need to do
3. Can do most things, but pain gets in the way of some
4. Can do everything I need to do
The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported
Measured: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Normal sleep" will be reported
Measured: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Normal sleep" will be reported
Measured: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
1. Awake with pain most of the night
2. Awake with occasional pain
3. Normal sleep
The percentage of patients whose sleep is reported as "Normal sleep" will be reported
Measured: 3) Third postoperative day
Analgesic Requirements - First postoperative day
Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
Measured: 1) First postoperative day
Analgesic Requirements - Second postoperative day
Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
Measured: 2) Second postoperative day
Analgesic Requirements - Third postoperative day
Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
Measured: 3) Third postoperative day
Kidney function - Furosemide requirement - Intraoperatively
Kidney function as quantified by furosemide requirement to maintain urine output. Data will be reported in mg.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Kidney function - Furosemide requirement - 24 hours postoperatively
Kidney function as quantified by furosemide requirement to maintain urine output. Data will be reported in mg.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Kidney function - MDRD GFR - Preoperatively
Kidney function as assessed by preoperative GFR calculated by the MDRD GFR equation.
Measured: 1) Preoperatively (as a baseline)
Kidney function - MDRD GFR - Immediately postoperatively
Kidney function as assessed by postoperative GFR calculated by the MDRD GFR equation.
Measured: 2) At the end of surgery 1h after the end of placement of last suture/surgical clip on patient, upon ICU admission.
Kidney function - MDRD GFR - 24h Postoperatively
Kidney function as assessed by postoperative GFR calculated by the MDRD GFR equation.
Measured: 3) 24h postoperatively
Kidney function - Urine Output - Intraoperatively
Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg*h.
Measured: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Kidney function - Urine Output - 24 hours postoperatively
Kidney function as quantified by urine output. Data will be reported as an averaged rate in ml/kg*h.
Measured: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Length of stay - ICU
All patients will spend at least 1 day in the ICU for postoperative monitoring. ICU length of stay will be reported in days.
Measured: From day of surgery until day of ICU stay.
Length of stay - Hospital Discharge
Hospital length of stay will be reported in days.
Measured: From day of surgery until hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20201 Sep 2027

First posted20 May 2021
Study start8 Oct 2020
Primary completion1 Sep 2026 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Elective Surgical ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Implementation of a multimodal anesthetic opioid-free strategy, that includes the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is anticipated to modulate the inflammatory and stress response, as measured by levels of inflammatory markers and haemodynamic stability, compared to conventional anesthetic opioid-based techniques. Furthermore, a decreased inflammatory and stress response, as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04894864
Sponsor's protocol ID: OFA-aneurysm
Status last verified: Jun 2026
First submitted: 19 Apr 2021
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Norman PE, Semmens JB, Lawrence-Brown MM. Long-term relative survival following surgery for abdominal aortic aneurysm: a review. Cardiovasc Surg. 2001 Jun;9(3):219-24. doi: 10.1177/096721090100900303.
PubMed 11336844
Johal AS, Loftus IM, Boyle JR, Heikkila K, Waton S, Cromwell DA. Long-term survival after endovascular and open repair of unruptured abdominal aortic aneurysm. Br J Surg. 2019 Dec;106(13):1784-1793. doi: 10.1002/bjs.11215.
PubMed 31747067
Moris DN, Kontos MI, Mantonakis EI, Athanasiou AK, Spartalis ED, Bakoyiannis CN, Chrousos GP, Georgopoulos SE. Concept of the aortic aneurysm repair-related surgical stress: a review of the literature. Int J Clin Exp Med. 2014 Sep 15;7(9):2402-12. eCollection 2014.
PubMed 25356092
Tsilimigras DI, Sigala F, Karaolanis G, Ntanasis-Stathopoulos I, Spartalis E, Spartalis M, Patelis N, Papalampros A, Long C, Moris D. Cytokines as biomarkers of inflammatory response after open versus endovascular repair of abdominal aortic aneurysms: a systematic review. Acta Pharmacol Sin. 2018 Jul;39(7):1164-1175. doi: 10.1038/aps.2017.212. Epub 2018 May 17.
PubMed 29770795
Pearson S, Hassen T, Spark JI, Cabot J, Cowled P, Fitridge R. Endovascular repair of abdominal aortic aneurysm reduces intraoperative cortisol and perioperative morbidity. J Vasc Surg. 2005 Jun;41(6):919-25. doi: 10.1016/j.jvs.2005.02.040.
PubMed 15944585
Wilt TJ, Lederle FA, Macdonald R, Jonk YC, Rector TS, Kane RL. Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm. Evid Rep Technol Assess (Full Rep). 2006 Aug;(144):1-113.
PubMed 17764213
Moore WS, Kashyap VS, Vescera CL, Quinones-Baldrich WJ. Abdominal aortic aneurysm: a 6-year comparison of endovascular versus transabdominal repair. Ann Surg. 1999 Sep;230(3):298-306; discussion 306-8. doi: 10.1097/00000658-199909000-00003.
PubMed 10493477
Salartash K, Sternbergh WC 3rd, York JW, Money SR. Comparison of open transabdominal AAA repair with endovascular AAA repair in reduction of postoperative stress response. Ann Vasc Surg. 2001 Jan;15(1):53-9. doi: 10.1007/s100160010014.
PubMed 11221945
Panaretou V, Siafaka I, Theodorou D, Manouras A, Seretis C, Gourgiotis S, Katsaragakis S, Sigala F, Zografos G, Filis K. Combined general-epidural anesthesia with continuous postoperative epidural analgesia preserves sigmoid colon perfusion in elective infrarenal aortic aneurysm repair. Saudi J Anaesth. 2012 Oct-Dec;6(4):373-9. doi: 10.4103/1658-354X.105870.
PubMed 23493852
Jessula S, Atkinson L, Casey P, Kwofie K, Stewart S, Lee MS, Smith M, Herman CR. Surgically positioned paravertebral catheters and postoperative analgesia after open abdominal aortic aneurysm repair. J Vasc Surg. 2019 Nov;70(5):1479-1487. doi: 10.1016/j.jvs.2019.02.037. Epub 2019 May 29.
PubMed 31153699
Panaretou V, Toufektzian L, Siafaka I, Kouroukli I, Sigala F, Vlachopoulos C, Katsaragakis S, Zografos G, Filis K. Postoperative pulmonary function after open abdominal aortic aneurysm repair in patients with chronic obstructive pulmonary disease: epidural versus intravenous analgesia. Ann Vasc Surg. 2012 Feb;26(2):149-55. doi: 10.1016/j.avsg.2011.04.009. Epub 2011 Oct 22.
PubMed 22018500
Greco KJ, Brovman EY, Nguyen LL, Urman RD. The Impact of Epidural Analgesia on Perioperative Morbidity or Mortality after Open Abdominal Aortic Aneurysm Repair. Ann Vasc Surg. 2020 Jul;66:44-53. doi: 10.1016/j.avsg.2019.10.054. Epub 2019 Oct 28.
PubMed 31672606
Ammar AS, Mahmoud KM. Comparative effect of propofol versus sevoflurane on renal ischemia/reperfusion injury after elective open abdominal aortic aneurysm repair. Saudi J Anaesth. 2016 Jul-Sep;10(3):301-7. doi: 10.4103/1658-354X.174907.
PubMed 27375385
Loggi S, Mininno N, Damiani E, Marini B, Adrario E, Scorcella C, Domizi R, Carsetti A, Pantanetti S, Pagliariccio G, Carbonari L, Donati A. Changes in the sublingual microcirculation following aortic surgery under balanced or total intravenous anaesthesia: a prospective observational study. BMC Anesthesiol. 2019 Jan 5;19(1):1. doi: 10.1186/s12871-018-0673-7.
PubMed 30611197
Giudice V, Lauwick S, Kaba A, Joris J. [Proven and expected benefits of intravenous lidocaine administered during the perioperative period]. Rev Med Liege. 2012 Feb;67(2):81-4. French.
PubMed 22482237

Interested in taking part?

George Papastratigakis, MD

00306979056672

papastratigakisg@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study
ClinicalTrials.gov ID: NCT04894864
Acronym / sponsor ID: OFA-aneurysm
Conditions: Elective Surgical Procedures, Postoperative Pain, Anesthesia, Opioid Use, Abdominal Aortic Aneurysm Without Rupture, Vascular Surgical Procedure
Keywords: Opioid-free Anesthesia-Analgesia, Cytokines, Opioid-based Anesthesia-Analgesia, Haemodynamic Stability, Open Abdominal Aortic Aneurysm Repair, Immunomodulation, Inflammatory Markers
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: University of CreteUniversity, hospital or other
Collaborators: University Hospital of Crete
Study start: 8 Oct 2020 (actual)
Primary completion: 1 Sep 2026 (estimated)
Study completion: 1 Sep 2027 (estimated)
First posted: 20 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Implementation of a multimodal anesthetic opioid-free strategy, that includes the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is anticipated to modulate the inflammatory and stress response, as measured by levels of inflammatory markers and haemodynamic stability, compared to conventional anesthetic opioid-based techniques. Furthermore, a decreased inflammatory and stress response, as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.

Arm	Type	Receives
Opioid-Based Anesthesia Analgesia	Active comparator	Drug: Opioid-Based Anesthesia-Analgesia StrategyPremedication: IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Propofol 2-3mg/kg, Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg. Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg/kg, Fentanyl 1-2mcg/kg during induction and 50-100mcg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. ICU stay sedation: Remifentanil infusion, until removal of the endotracheal tube. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g x3 +/- Dexketoprofen trometamol 50mg x2. Rescue therapy only: Tramadol 50-100mg.
Opioid-Free Anesthesia Analgesia	Active comparator	Drug: Opioid-free Anesthesia-Analgesia StrategyPremedication: Pregabalin 50-150mg x2, IM Midazolam 0.05-0.07mg/kg. Anesthesia induction: Midazolam 0.03mg/kg, Dexdmedetomidine 0.5-1mcg/kg, Lidocaine 1mg/kg, Propofol 2-3mg/kg, Ketamine 1-1.5mg/kg, Hyoscine 10mg, Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/kg, Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg. Anesthesia maintenance: Desflurane set at ~1 MAC, Dexmedetomidine 0.2-1.2mcg/kg/h, Lidocaine 0.5-1mg/kg/h, Ketamine 0.3-0.5mg/kg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. ICU sedation: Dexmedetomidine + Lidocaine infusions, until removal of the ETT. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os x1 and 25mg x1, up to x2, Paracetamol 1g x3 +/- Dexketoprofen trometamol 50mg x2. Rescue therapy only: Tramadol 50-100mg.

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient Consent
Age between 40 and 85 years old
Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair

Key exclusion criteria (8 listed)

Immunocompromised patients
Patients with active infection
Reoperation on the aorta
Inflammatory bowel Disease
Malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opioid-Based Anesthesia-Analgesia StrategyAlso: Opioid-Based Anesthesia, OBA-AA perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.	Drug	Opioid-Based Anesthesia Analgesia
Opioid-free Anesthesia-Analgesia StrategyAlso: Opioid-Free Anesthesia, OFA-AA perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.	Drug	Opioid-Free Anesthesia Analgesia

Primary outcome

Surgical Stress Response - IL-6 - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-8 - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-10 - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Copeptin - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Copeptin - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Copeptin - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by Copeptin serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Copeptin - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - TNF-a - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Cortisol - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - CRP - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - WBC - Preoperatively
Time frame: 1) Preoperatively (as a baseline)
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp
Time frame: 2) 15 minutes after aortic cross-clamping
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp
Time frame: 3) 60 minutes after aortic cross-clamp release
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release
Time frame: 4) 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups.
Haemodynamic Stability - Tachycardia
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in as a percentage of the total surgical time in which the participant exhibited tachycardia.
Haemodynamic Stability - Bradycardia
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Intraoperative Bradycardia (defined as PR≤ 40 bpm), with episodes lasting ≥1 minute. Data will be reported in as a percentage of the total surgical time in which the participant exhibited bradycardia.
Haemodynamic Stability - Hypotension SBP
Time frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Intraoperative Hypotension (defined as SBP≤90mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypotension, based on the SBP values.
Haemodynamic Stability - Hypotension MBP
Time frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Intraoperative Hypotension (defined as MBP≤65mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative MBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute MPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypotension, based on the MBP values.
Haemodynamic Stability - Hypertension
Time frame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Intraoperative Hypertension (defined as SBP ≥120% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in as a percentage of the total surgical time in which the participant exhibited hypertension, based on the SBP values.
Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements averaged over the total surgical time. Data will be reported in ml/kg*h.
Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements. Data will be reported in ml/kg*h.
Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements averaged over the total surgical time. Data will be reported in ml/kg*h.
Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements. Data will be reported in ml/kg*h.
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml.
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml.
Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml.
Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml.
Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml.
Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml.
Haemodynamic Stability - Blood Loss - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml.
Haemodynamic Stability - Blood Loss - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml.
Haemodynamic Stability - Fluid Balance - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance averaged over the total surgical time. Data will be reported in ml/kg/h
Haemodynamic Stability - Fluid Balance - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance. Data will be reported in ml.
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg.
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg.
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg.
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg.
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements.Data will be reported as an averaged rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively
Time frame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min.
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively
Time frame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged rate in mcg/kg*min.

71 secondary outcomes

Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively
Time frame: 1) Immediately postoperatively (if awakened prior to ICU admission)
Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day
Time frame: 2) First postoperative day
Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day
Time frame: 3) Second postoperative day
Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day
Time frame: 4) Third postoperative day
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively
Time frame: 1) Immediately postoperatively (if awakened prior to ICU admission)
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day
Time frame: 2) First postoperative day
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day
Time frame: 3) Second postoperative day
Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day
Time frame: 4) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day
Time frame: 2) Second postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day
Time frame: 3) Third postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day
Time frame: 1) First postoperative day
Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day
Time frame: 2) Second postoperative day

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Background: PubMed 11336844Norman PE, Semmens JB, Lawrence-Brown MM. Long-term relative survival following surgery for abdominal aortic aneurysm: a review. Cardiovasc Surg. 2001 Jun;9(3):219-24. doi: 10.1177/096721090100900303.
Background: PubMed 31747067Johal AS, Loftus IM, Boyle JR, Heikkila K, Waton S, Cromwell DA. Long-term survival after endovascular and open repair of unruptured abdominal aortic aneurysm. Br J Surg. 2019 Dec;106(13):1784-1793. doi: 10.1002/bjs.11215.
Background: PubMed 25356092Moris DN, Kontos MI, Mantonakis EI, Athanasiou AK, Spartalis ED, Bakoyiannis CN, Chrousos GP, Georgopoulos SE. Concept of the aortic aneurysm repair-related surgical stress: a review of the literature. Int J Clin Exp Med. 2014 Sep 15;7(9):2402-12. eCollection 2014.
Background: PubMed 29770795Tsilimigras DI, Sigala F, Karaolanis G, Ntanasis-Stathopoulos I, Spartalis E, Spartalis M, Patelis N, Papalampros A, Long C, Moris D. Cytokines as biomarkers of inflammatory response after open versus endovascular repair of abdominal aortic aneurysms: a systematic review. Acta Pharmacol Sin. 2018 Jul;39(7):1164-1175. doi: 10.1038/aps.2017.212. Epub 2018 May 17.
Background: PubMed 15944585Pearson S, Hassen T, Spark JI, Cabot J, Cowled P, Fitridge R. Endovascular repair of abdominal aortic aneurysm reduces intraoperative cortisol and perioperative morbidity. J Vasc Surg. 2005 Jun;41(6):919-25. doi: 10.1016/j.jvs.2005.02.040.
Background: PubMed 17764213Wilt TJ, Lederle FA, Macdonald R, Jonk YC, Rector TS, Kane RL. Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm. Evid Rep Technol Assess (Full Rep). 2006 Aug;(144):1-113.
Background: PubMed 10493477Moore WS, Kashyap VS, Vescera CL, Quinones-Baldrich WJ. Abdominal aortic aneurysm: a 6-year comparison of endovascular versus transabdominal repair. Ann Surg. 1999 Sep;230(3):298-306; discussion 306-8. doi: 10.1097/00000658-199909000-00003.
Background: PubMed 11221945Salartash K, Sternbergh WC 3rd, York JW, Money SR. Comparison of open transabdominal AAA repair with endovascular AAA repair in reduction of postoperative stress response. Ann Vasc Surg. 2001 Jan;15(1):53-9. doi: 10.1007/s100160010014.
Background: PubMed 23493852Panaretou V, Siafaka I, Theodorou D, Manouras A, Seretis C, Gourgiotis S, Katsaragakis S, Sigala F, Zografos G, Filis K. Combined general-epidural anesthesia with continuous postoperative epidural analgesia preserves sigmoid colon perfusion in elective infrarenal aortic aneurysm repair. Saudi J Anaesth. 2012 Oct-Dec;6(4):373-9. doi: 10.4103/1658-354X.105870.
Background: PubMed 31153699Jessula S, Atkinson L, Casey P, Kwofie K, Stewart S, Lee MS, Smith M, Herman CR. Surgically positioned paravertebral catheters and postoperative analgesia after open abdominal aortic aneurysm repair. J Vasc Surg. 2019 Nov;70(5):1479-1487. doi: 10.1016/j.jvs.2019.02.037. Epub 2019 May 29.
Background: PubMed 22018500Panaretou V, Toufektzian L, Siafaka I, Kouroukli I, Sigala F, Vlachopoulos C, Katsaragakis S, Zografos G, Filis K. Postoperative pulmonary function after open abdominal aortic aneurysm repair in patients with chronic obstructive pulmonary disease: epidural versus intravenous analgesia. Ann Vasc Surg. 2012 Feb;26(2):149-55. doi: 10.1016/j.avsg.2011.04.009. Epub 2011 Oct 22.
Background: PubMed 31672606Greco KJ, Brovman EY, Nguyen LL, Urman RD. The Impact of Epidural Analgesia on Perioperative Morbidity or Mortality after Open Abdominal Aortic Aneurysm Repair. Ann Vasc Surg. 2020 Jul;66:44-53. doi: 10.1016/j.avsg.2019.10.054. Epub 2019 Oct 28.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

George Papastratigakis, MD contact

00306979056672

papastratigakisg@gmail.com

Georgios Stefanakis, MD contact

00306978779726

G_Stefanakis@yahoo.com

Vasileia Nyktari, MD,PhD study chair

University of Crete, Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact George Papastratigakis, MD (00306979056672, papastratigakisg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Stress Response - IL-6 - Preoperatively (time frame: 1) Preoperatively (as a baseline)). The study lists 65 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04894864, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.