MedDataX Logo

Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

NCT ID: NCT05004519

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Opioid free anesthesia is a recent anesthesia technique with the aim to avoid peroperative use of morphinics to allow a diminution of secondary morphinics effects in the postoperative period.

There is no robust data on the real benefits of such procedures. Obese patients are particular at risk of secondary effects of opioids. The aim of our study is to compare opioid free anesthesia to multimodal anesthesia on postoperative morphine consumption after a laparoscopic gastric bypass.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the study is to study the impact of an opioid free anesthesia protocol on the postoperative morphine consumption in laparoscopic gastric bypass compared to a multimodal anesthesia protocol.

183 morbidly obese patients (Body mass index \>40Kg/m2 or \>35kg/m2 AND/OR diabete mellitus AND/OR sleep apnea syndrome AND/OR arterial hypertension.

A randomization will allocate two groups of 100 patients in:

* Group 1: Multimodal anesthesia without opioids
* Group 2: Multimodal anesthesia with opioid The patient, the anesthesist and the data evaluator will be all blinded about the allocation of the patient.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesics, Opioid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opioid free anesthesia

Dexmedetomidine 0,5 microgrammes/kg of ideal body weight (IBW) + magnesium 40 mg/kg of total body weight (TBW) in 10 minutes

* Dexmedetomidine 0,4- 0,8 microgrammes/kg of IBW/h;Lidocaine 2% 49ml+ Ketamine 50mg: 1ml/10kg of IBW/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if \>120 kg, 3g if \>120Kg;Paracetamol 15 mg/ KgTBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;dexmedetomidine: 0,4-0,8 microgramme/kg/h;Rocuronium 0,1 mg/kg of IBW if posttetanic count\>1/10;Atropine 0,5 mg if heart rate \< 40/min;Ephedrine 5mg in Arterial mean pressure \< 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure \> 20% of basal value Emergence
* Stop dexmedetomidine;Stop sevorane;1 ml of NaCL 0,9%;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Lidocaïne 2% 49ml + Ketamine 50 mg: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Multimodal anesthesia

magnesium 40 mg/kg of total body weight (TBW) in 10 minutes

* Remifentanil 0,2-0,4 microgrammes/kg/min of ideal body weight; Saline 0,9%: Infusion at 1ml/10kg of ideal body weight/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if \>120 kg, 3g if \>120Kg;Paracetamol 15 mg/ Kg TBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;remifentanil 0,2-0,4 microgrammes/kg/min;Rocuronium 0,1 mg/kg of IBW if posttetanic count\>1/10;Atropine 0,5 mg if heart rate \< 40/min;Ephedrine 5mg in Arterial mean pressure \< 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure \> 20% of basal value Emergence
* Stop remifentanil;Stop sevorane;1 ml of morphine 10mg/ml;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Salne 50ml: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine Injection [Precedex]

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Intervention Type DRUG

Remifentanil

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* American Society of anesthesia score (ASA) 2-3
* Scheduled for a laparoscopic gastric bypass surgery

Exclusion Criteria

* Patient refusal
* Medical diseases: Cardiac arrhythmia like atrioventricular block 2nd or 3rd degree, pacemaker, arterial hypotension, severe bradycardia, cerebrovascular pathology, renal and/or hepatic insufficiency
* Previous bariatric surgery
* Allergy to any medication used during the surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

matthieu clanet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

matthieu clanet

Head of anesthesia department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

matthieu Clanet

Role: PRINCIPAL_INVESTIGATOR

Chirec

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHIREC Delta Hospital

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Clanet M, Touihri K, El Haddad C, Goldsztejn N, Himpens J, Fils JF, Gricourt Y, Van der Linden P, Coeckelenbergh S, Joosten A, Dandrifosse AC. Effect of opioid-free versus opioid-based strategies during multimodal anaesthesia on postoperative morphine consumption after bariatric surgery: a randomised double-blind clinical trial. BJA Open. 2024 Feb 23;9:100263. doi: 10.1016/j.bjao.2024.100263. eCollection 2024 Mar.

Reference Type DERIVED
PMID: 38435809 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P2021/378

Identifier Type: -

Identifier Source: org_study_id