Clinical trial NCT05004519: Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesics, Opioid
Lead sponsor: Chirec
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Morphine consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Visual analog scale
timeFrame: Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
measure: Morphine consumption
timeFrame: Post Anesthesia Care Unit admission (Hour 0), Hour +4
measure: Quality of Recovery 40 score
timeFrame: operative Day -1, Operative day +1, operative day +30
measure: Hypoxemia
timeFrame: up to patient discharge
measure: Postoperative Nausea and vomiting
timeFrame: Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
measure: Need of Antiemetics
timeFrame: Up to patient discharge
measure: Bradycardia and use of atropine
timeFrame: Up to patient discharge
measure: Readmissions rate
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHIREC Delta Hospital
Study officials:
affiliation: Chirec
name: matthieu Clanet
role: PRINCIPAL_INVESTIGATOR
References: