ObesityNCT06714981
Hemodynamics Stability During Opioid Free Anesthesia for Patients with Obesity
A study testing Opioid Free Anaesthesia and Opioid based Anesthesia in people with Obesity and General Anesthesia, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The study evaluated the impact of Opioid-Free Anesthesia (OFA) and Fentanyl Anesthesia (FNT) on the hemodynamics of the circulatory system (HR, esCCO, esCCI, esSVI, BP: SYS, DIA, MEAN) in obese patients with a BMI > 40 undregoing laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, General Anesthesia, Opioid Free Anaesthesia
- What is being tested?
- Opioid Free Anaesthesia and Opioid based Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2022to 2 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese patients with a BMI > 40 kg/m2 undergoing elective laparoscopic bariatric surgery
Who cannot join
- lack of consent
- emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Opioid-Free Anesthesia (OFA) and Standard Fentanyl-based General Anesthesia in Patients with Morbid Obesity Undergoing Laparoscopic Bariatric Surgery
The study evaluated the impact of Opioid-Free Anesthesia (OFA) and Fentanyl Anesthesia (FNT) on the hemodynamics of the circulatory system (HR, esCCO, esCCI, esSVI, BP: SYS, DIA, MEAN) in obese patients with a BMI > 40 undregoing laparoscopic bariatric surgery. Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Maintenance: continuous infusion of ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane.
Read the detailed description
Adult patients (over 18 years old) with a BMI ≥ 40, ASA ≤ II, qualified for elective bariatric surgery under general anesthesia with endotracheal intubation, who provided informed, voluntary consent to participate in the study, were included. Patients with BMI < 40, ASA III and above, heart failure, arrhythmias (especially bradyarrhythmia), hypovolemia, shock, unstable coronary artery disease, autonomic neuropathy with orthostatic hypotension, with a history of allergic reactions, pregnancy, indications for urgent surgical intervention, or those who did not consent to participate in the study, were excluded. Patients' weight, height, and BMI were measured. All obtained data were anonymized.
After transporting the patient to the operating room, the envelope was opened, and the patient was assigned to either the OFA or FNT anesthesia group.
Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Induction: after three minutes of preoxygenation with 100% oxygen, propofol 2.5 mg/kg (actual body weight) was administered. Following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) was given. Bag-mask ventilation with 100% oxygen continued for 3 minutes. After achieving full neuromuscular blockade, confirmed by the loss of all four responses using a peripheral nerve stimulator, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC sevoflurane. Maintenance: ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight). The patients were also administered ephedrine in case of hypotension, atropine for bradycardia, and beta-blockers for tachycardia and hypertension.
Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. Bag-mask ventilation with 100% oxygen and 2% inhaled sevoflurane continued for 3 minutes. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane. Maintenance dose for fentanyl was 0.003-0.006 µg/kg/min (corrected body weight) and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight).
During induction, patients were positioned supine with the head and torso elevated at a 25-degree angle on a positioning pad. Anesthetic monitoring included HR, NIPC-SYS, NIPC-MEAN, NIPC-DIA, SpO2, esCCO, esCCI, and esSVI using the Vismo monitor and EtCO2.
Hemodynamic parameters (esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR) were measured before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10).
The objective of the study is to compare the impact of OFA on hemodynamic parameters measured by non-invasive technique: esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR, in obese patients with BMI > 40, with those obtained during the commonly used FNT anesthesia.
- Conditions
- Obesity, General Anesthesia, Opioid Free Anaesthesia
- Being tested
- Opioid Free Anaesthesia, Opioid based Anesthesia
- Keywords
- general anesthesia, Opioid-Free Anesthesia, obesity, fentanyl, hemodynamics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free AnaesthesiaDrug
patients received opioid free anesthesia
Opioid based AnesthesiaDrug
patients received opioid based anesthesia
| Study group | Role | What they receive |
|---|---|---|
| opioid free anesthesia | Experimental | patients received opioid free anesthesia Receives: Drug: Opioid Free Anaesthesia |
| opioid based anesthesia | Active comparator | patients received opioid based anesthesia Receives: Drug: Opioid based Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic stability, cardiac output
Hemodynamic parameters (esCCO - cardiac output l/min) were measured using Visimo monitor.
Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
hemodynamic stability esCCI - cardiac index
Cardiac index esCCI - l/m2 was measured using Visimo monitor.
Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
hemodynamic stability esSVI
Stroke voulme esSVI - l were measured using Visimo monitor.
Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
hemodynamic stability: arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA
Arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA (mmHg) were measured using Visimo monitor.
Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
hemodynamic stability HR - heart rate
HR were measured using Visimo monitor.
Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start2 Jan 2022
- Primary completion2 Jan 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Gaszynski, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714981
- Sponsor's protocol ID
- RNN/60/16/KE
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Opioid-Free Anesthesia (OFA) and Standard Fentanyl-based General Anesthesia in Patients with Morbid Obesity Undergoing Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06714981
- Acronym / sponsor ID
- RNN/60/16/KE
- Conditions
- Obesity, General Anesthesia, Opioid Free Anaesthesia
- Keywords
- general anesthesia, Opioid-Free Anesthesia, obesity, fentanyl, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 4 Dec 2024 (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 study evaluated the impact of Opioid-Free Anesthesia (OFA) and Fentanyl Anesthesia (FNT) on the hemodynamics of the circulatory system (HR, esCCO, esCCI, esSVI, BP: SYS, DIA, MEAN) in obese patients with a BMI > 40 undregoing laparoscopic bariatric surgery. Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Maintenance: continuous infusion of ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane.
Detailed description
Adult patients (over 18 years old) with a BMI ≥ 40, ASA ≤ II, qualified for elective bariatric surgery under general anesthesia with endotracheal intubation, who provided informed, voluntary consent to participate in the study, were included. Patients with BMI < 40, ASA III and above, heart failure, arrhythmias (especially bradyarrhythmia), hypovolemia, shock, unstable coronary artery disease, autonomic neuropathy with orthostatic hypotension, with a history of allergic reactions, pregnancy, indications for urgent surgical intervention, or those who did not consent to participate in the study, were excluded. Patients' weight, height, and BMI were measured. All obtained data were anonymized.
After transporting the patient to the operating room, the envelope was opened, and the patient was assigned to either the OFA or FNT anesthesia group.
Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Induction: after three minutes of preoxygenation with 100% oxygen, propofol 2.5 mg/kg (actual body weight) was administered. Following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) was given. Bag-mask ventilation with 100% oxygen continued for 3 minutes. After achieving full neuromuscular blockade, confirmed by the loss of all four responses using a peripheral nerve stimulator, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC sevoflurane. Maintenance: ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight). The patients were also administered ephedrine in case of hypotension, atropine for bradycardia, and beta-blockers for tachycardia and hypertension.
Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. Bag-mask ventilation with 100% oxygen and 2% inhaled sevoflurane continued for 3 minutes. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane. Maintenance dose for fentanyl was 0.003-0.006 µg/kg/min (corrected body weight) and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight).
During induction, patients were positioned supine with the head and torso elevated at a 25-degree angle on a positioning pad. Anesthetic monitoring included HR, NIPC-SYS, NIPC-MEAN, NIPC-DIA, SpO2, esCCO, esCCI, and esSVI using the Vismo monitor and EtCO2.
Hemodynamic parameters (esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR) were measured before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10).
The objective of the study is to compare the impact of OFA on hemodynamic parameters measured by non-invasive technique: esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR, in obese patients with BMI > 40, with those obtained during the commonly used FNT anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid free anesthesia | Experimental | Drug: Opioid Free Anaesthesiapatients received opioid free anesthesia |
| opioid based anesthesia | Active comparator | Drug: Opioid based Anesthesiapatients received opioid based anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obese patients with a BMI > 40 kg/m2 undergoing elective laparoscopic bariatric surgery
Key exclusion criteria (2 listed)
- lack of consent
- emergency operation
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 Free Anaesthesiapatients received opioid free anesthesia | Drug | opioid free anesthesia |
| Opioid based Anesthesiapatients received opioid based anesthesia | Drug | opioid based anesthesia |
Primary outcome
hemodynamic stability, cardiac output
Time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
Hemodynamic parameters (esCCO - cardiac output l/min) were measured using Visimo monitor.
hemodynamic stability esCCI - cardiac index
Time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
Cardiac index esCCI - l/m2 was measured using Visimo monitor.
hemodynamic stability esSVI
Time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
Stroke voulme esSVI - l were measured using Visimo monitor.
hemodynamic stability: arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA
Time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
Arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA (mmHg) were measured using Visimo monitor.
hemodynamic stability HR - heart rate
Time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
HR were measured using Visimo monitor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Free Anaesthesia and Opioid based Anesthesia in people with Obesity and General Anesthesia, run by Medical University of Lodz at 1 site in Poland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 4 Dec 2024. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic stability, cardiac output (time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)). 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?
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 4 Dec 2024.