Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

NCT05004519 | Completed

• 1 other identifier: P2021/378
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesics, Opioid

Outcome Measures

Primary Outcomes (1)

• Total Morphine consumption

  total morphine consumption from the PACU arrival to the 24 h post-surgery

  24 hours after surgery

Secondary Outcomes (8)

• Visual analog scale

  Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24

• Morphine consumption

  Post Anesthesia Care Unit admission (Hour 0), Hour +4

• Quality of Recovery 40 score

  operative Day -1, Operative day +1, operative day +30

• Hypoxemia

  up to patient discharge

• Postoperative Nausea and vomiting

  Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24

Study Arms (2)

Opioid free anesthesia

EXPERIMENTAL

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

Drug: Dexmedetomidine Injection [Precedex]

Multimodal anesthesia

EXPERIMENTAL

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

Drug: Remifentanil

Interventions

Dexmedetomidine Injection [Precedex] DRUG

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Opioid free anesthesia

Remifentanil DRUG

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Multimodal anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• matthieu clanet: lead

Study Sites (1)

CHIREC Delta Hospital

Brussels, 1160, Belgium

Location

Related Publications (1)

• 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.

  PMID: 38435809 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• matthieu Clanet

  Chirec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of anesthesia department

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 13, 2021
• Study Start: October 5, 2021
• Primary Completion: September 15, 2022
• Study Completion: October 15, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)