Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

matthieu clanet183 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

183

Conditions

Analgesics, Opioid

Interventions

Dexmedetomidine Injection [Precedex]DRUG

dexmedetomidine or remifentanil during laparoscopic gastric bypass

RemifentanilDRUG

dexmedetomidine or remifentanil during laparoscopic gastric bypass

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

CHIREC Delta Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

Total Morphine consumption

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

Time frame: 24 hours after surgery

Secondary Outcomes

Visual analog scale

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

Morphine consumption

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

Quality of Recovery 40 score

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

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

Hypoxemia

SpO2 \< 90% on 2 liters of nasal Oxygen

Time frame: up to patient discharge

Postoperative Nausea and vomiting

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

Need of Antiemetics

Time frame: Up to patient discharge

Bradycardia and use of atropine

Time frame: Up to patient discharge

Readmissions rate

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

Time frame: Up to 30 days

Data from ClinicalTrials.gov

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