Pain, PostoperativeNCT05089526
Opioid-free Anesthesia in Laparoscopic Cholecystectomies
A study testing ketamine-lidocaine-dexmedetomidine and fentanyl in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic cholecystectomies Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Pain, Chronic
- What is being tested?
- ketamine-lidocaine-dexmedetomidine and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 11 Oct 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective laparoscopic cholecystectomy
Who cannot join
- body mass index (BMI) >35 kg/m2
- contraindications to local anesthetic administration or non-steroidal agents administration
- systematic use of analgesic agents preoperatively
- chronic pain syndromes preoperatively
- neurological or psychiatric disease on treatment
- pregnancy
Show all 11Show fewer
- severe hepatic or renal disease
- history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- bradycardia(<55 beats/minute)
- drug or alcohol abuse
- language or communication barriers lack of informed consent
Trial locations and contacts
1 site in 1 country.
Kyriakos Kyriazos contact
Greece1 site, 1 recruiting
- Recruiting
Evangelismos General Hospital
Athens
Kyriakos Kyriazos, MD, kyriakos.kyriazos5@gmail.com
About this study
Official title: Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine in Laparoscopic Cholecystectomies
The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic cholecystectomies
Read the detailed description
Inadequately treated postoperative pain after laparoscopic cholecystectomy may untowardly affect early recovery and also lead to the development of chronic pain. Laparoscopic surgery is associated with diminished postoperative pain but this does not mean that patients subjected to laparoscopic operations are not in need for analgesia intra- and postoperatively. Pneumoperitoneum can lead to postoperative discomfort and occasionally intense postoperative shoulder pain. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.
Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay. In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, dexmedetomidine is a highly selective alfa-2 adreno-ceptor agonist that provides sedation, analgesia, and sympatholysis. Its perioperative intravenous administration has been associated with a reduction in postoperative pain intensity, analgesic consumption and nausea. There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations can be used towards the achievement of a completely opioid-free anesthetic regimen. Additionally, it can be hypothesized that the combination of non-opioid drugs with different targets can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of opioids. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine-ketamine-dexmedetomidine versus fentanyl on recovery profile and postoperative pain after elective laparoscopic cholecystectomy.
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chronic, Cholecystectomy, Ketamine, Dexmedetomidine
- Being tested
- ketamine-lidocaine-dexmedetomidine, fentanyl
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine-lidocaine-dexmedetomidineDrug
Also called KLD group
In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving
1mL/10kg/h of the aforementioned solution.
fentanylDrug
Also called Control group
In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| ketamine-lidocaine-dexmedetomidine (KLD) group | Active comparator | combination of ketamine-lidocaine-dexmedetomidine in one syringe Receives: Drug: ketamine-lidocaine-dexmedetomidine |
| fentanyl (control) group | Active comparator | syringe of fentanyl Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score on arrival to Post-Anesthesia Care Unit (PACU)
pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: immediately postoperatively
pain score at discharge from Post-Anesthesia Care Unit (PACU)
pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
pain score 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 3 hours postoperatively
pain score 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 6 hours postoperatively
pain score 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Measured: 24 hours postoperatively
Secondary outcomes (19)
Post Anesthesia Care Unit (PACU) duration of stay
duration of patient stay at PACU
Measured: immediately postoperatively
sedation on arrival to Post-Anesthesia Care Unit
sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
Measured: immediately postoperatively
sedation at discharge from Post-Anesthesia Care (PACU) Unit
sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
Measured: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
sevoflurane consumption during general anesthesia
the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined
Measured: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
time to first request for analgesia
the time for the first patient request for analgesia will be noted
Measured: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
mg of morphine requested during patient PACU stay
Measured: immediately postoperatively
tramadol consumption in the first 24 hours
patients will be followed for cumulative tramadol consumption for 24 hours postoperatively
Measured: 24 hours postoperatively
sleep quality
subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality
Measured: 24 hours postoperatively
first mobilization after surgery
patients will be questioned regarding the time at which they mobilized after surgery
Measured: 24 hours postoperatively
gastrointestinal recovery after surgery
patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery
Measured: 24 hours postoperatively
satisfaction from postoperative analgesia
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
Measured: 24 hours postoperatively
first fluid intake
patients will be questioned regarding the time they had their first fluid intake
Measured: 24 hours postoperatively
first solid intake
patients will be questioned regarding the time they had their first solid intake
Measured: 24 hours postoperatively
hospitalization time
duration of hospital stay after surgery in hours
Measured: 96 hours postoperatively
fentanyl requirement during surgery
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Measured: intraoperatively
side effects intraoperatively
patients will be monitored for side-effects of the administered agents intraoperatively
Measured: intraoperatively
side effects postoperatively
patients will be monitored for side-effects of the administered agents postoperatively
Measured: 48 hours postoperatively
incidence of chronic pain 1 month after surgery
occurrence of chronic pain at the site of the operation 1 month after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Measured: 1 month after surgery
incidence of chronic pain 3 months after surgery
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start11 Oct 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089526
- Sponsor's protocol ID
- lap-chol-opioid free
- Status last verified
- Feb 2023
- First submitted
- 10 Oct 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
PubMed 29739537Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
PubMed 30802933Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632.
PubMed 29994942Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. No abstract available. English, Spanish.
PubMed 28431750Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.
PubMed 29739542Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232.
PubMed 28298760Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
PubMed 21061107De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
PubMed 23669270Toleska M, Dimitrovski A. Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2019 Oct 1;40(2):81-87. doi: 10.2478/prilozi-2019-0018.
PubMed 31605587Saadawy IM, Kaki AM, Abd El Latif AA, Abd-Elmaksoud AM, Tolba OM. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2010 May;54(5):549-56. doi: 10.1111/j.1399-6576.2009.02165.x. Epub 2009 Nov 16.
PubMed 19919581Lu J, Wang JF, Guo CL, Yin Q, Cheng W, Qian B. Intravenously injected lidocaine or magnesium improves the quality of early recovery after laparoscopic cholecystectomy: A randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S1-S8. doi: 10.1097/EJA.0000000000001348.
PubMed 33074940Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
PubMed 25925031
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine in Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT05089526
- Acronym / sponsor ID
- lap-chol-opioid free
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chronic, Cholecystectomy, Ketamine, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Oct 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.
The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic cholecystectomies
Detailed description
Inadequately treated postoperative pain after laparoscopic cholecystectomy may untowardly affect early recovery and also lead to the development of chronic pain. Laparoscopic surgery is associated with diminished postoperative pain but this does not mean that patients subjected to laparoscopic operations are not in need for analgesia intra- and postoperatively. Pneumoperitoneum can lead to postoperative discomfort and occasionally intense postoperative shoulder pain. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.
Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay. In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, dexmedetomidine is a highly selective alfa-2 adreno-ceptor agonist that provides sedation, analgesia, and sympatholysis. Its perioperative intravenous administration has been associated with a reduction in postoperative pain intensity, analgesic consumption and nausea. There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations can be used towards the achievement of a completely opioid-free anesthetic regimen. Additionally, it can be hypothesized that the combination of non-opioid drugs with different targets can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of opioids. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine-ketamine-dexmedetomidine versus fentanyl on recovery profile and postoperative pain after elective laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine-lidocaine-dexmedetomidine (KLD) group | Active comparator | Drug: ketamine-lidocaine-dexmedetomidinecombination of ketamine-lidocaine-dexmedetomidine in one syringe |
| fentanyl (control) group | Active comparator | Drug: fentanylsyringe of fentanyl |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective laparoscopic cholecystectomy
Key exclusion criteria (11 listed)
- body mass index (BMI) >35 kg/m2
- contraindications to local anesthetic administration or non-steroidal agents administration
- systematic use of analgesic agents preoperatively
- chronic pain syndromes preoperatively
- neurological or psychiatric disease on treatment
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 |
|---|---|---|
| ketamine-lidocaine-dexmedetomidineAlso: KLD groupIn the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution. | Drug | ketamine-lidocaine-dexmedetomidine (KLD) group |
| fentanylAlso: Control groupIn the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%. | Drug | fentanyl (control) group |
Primary outcome
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Time frame: immediately postoperatively
pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Time frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 3 hours postoperatively
Time frame: 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 6 hours postoperatively
Time frame: 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 24 hours postoperatively
Time frame: 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
19 secondary outcomes
Post Anesthesia Care Unit (PACU) duration of stay
Time frame: immediately postoperatively
sedation on arrival to Post-Anesthesia Care Unit
Time frame: immediately postoperatively
sedation at discharge from Post-Anesthesia Care (PACU) Unit
Time frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
sevoflurane consumption during general anesthesia
Time frame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
time to first request for analgesia
Time frame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
Time frame: immediately postoperatively
tramadol consumption in the first 24 hours
Time frame: 24 hours postoperatively
sleep quality
Time frame: 24 hours postoperatively
first mobilization after surgery
Time frame: 24 hours postoperatively
gastrointestinal recovery after surgery
Time frame: 24 hours postoperatively
satisfaction from postoperative analgesia
Time frame: 24 hours postoperatively
first fluid intake
Time frame: 24 hours postoperatively
first solid intake
Time frame: 24 hours postoperatively
hospitalization time
Time frame: 96 hours postoperatively
fentanyl requirement during surgery
Time frame: intraoperatively
side effects intraoperatively
Time frame: intraoperatively
side effects postoperatively
Time frame: 48 hours postoperatively
incidence of chronic pain 1 month after surgery
Time frame: 1 month after surgery
incidence of chronic pain 3 months after surgery
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 29739537Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
- Background: PubMed 30802933Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
- Background: PubMed 29994942Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632.
- Background: PubMed 28431750Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. No abstract available. English, Spanish.
- Background: PubMed 29739542Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.
- Background: PubMed 28298760Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232.
- Background: PubMed 21061107Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
- Background: PubMed 23669270De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
- Background: PubMed 31605587Toleska M, Dimitrovski A. Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2019 Oct 1;40(2):81-87. doi: 10.2478/prilozi-2019-0018.
- Background: PubMed 19919581Saadawy IM, Kaki AM, Abd El Latif AA, Abd-Elmaksoud AM, Tolba OM. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2010 May;54(5):549-56. doi: 10.1111/j.1399-6576.2009.02165.x. Epub 2009 Nov 16.
- Background: PubMed 33074940Lu J, Wang JF, Guo CL, Yin Q, Cheng W, Qian B. Intravenously injected lidocaine or magnesium improves the quality of early recovery after laparoscopic cholecystectomy: A randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S1-S8. doi: 10.1097/EJA.0000000000001348.
- Background: PubMed 25925031Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
- 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. This study is not recruiting at the moment.
Kyriakos Kyriazos contact
Kassiani Theodoraki principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine-lidocaine-dexmedetomidine and fentanyl in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.
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 11 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score on arrival to Post-Anesthesia Care Unit (PACU) (time frame: immediately postoperatively). The study lists 5 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 NCT05089526, which also lists 12 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 24 Feb 2023.