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Completed

NCT Number: NCT05004519

Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

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.

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Key information

Conditions

Analgesics, Opioid

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHIREC Delta Hospital

Brussels, 1160, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Injection [Precedex]

Drug

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Remifentanil

Drug

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Primary outcomes

  1. Total Morphine consumption

    Time frame: 24 hours after surgery

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

Secondary outcomes

  1. Visual analog scale

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

  2. Morphine consumption

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

  3. Quality of Recovery 40 score

    Time frame: operative Day -1, Operative day +1, operative day +30

    Recovery scale: From 40 (worst recovery) to 200 (Best Recovery)

  4. Hypoxemia

    Time frame: up to patient discharge

    SpO2 < 90% on 2 liters of nasal Oxygen

  5. Postoperative Nausea and vomiting

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

  6. Need of Antiemetics

    Time frame: Up to patient discharge

  7. Bradycardia and use of atropine

    Time frame: Up to patient discharge

  8. Readmissions rate

    Time frame: Up to 30 days

    Admission of the patient in hospital during the first 30 postoperative days

Sponsors and collaborators

Lead sponsor

matthieu clanet

Other

Registry information

Official study title

Impact of an Opioid Free Anesthesia Protocol Compared to Multimodal Anesthesia on Postoperative Morphine Consumption in an Enhanced Recovery After Gastric Bypass Surgery Protocol: a Prospective, Double Blind Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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