Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

Analgesics, Opioid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004519
• Other study ID #: P2021/378
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: November 2023
• Source: Chirec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesics, Opioid

Intervention

Drug:
• Dexmedetomidine Injection [Precedex]
dexmedetomidine or remifentanil during laparoscopic gastric bypass
• Remifentanil
dexmedetomidine or remifentanil during laparoscopic gastric bypass

Locations

Country	Name	City	State
Belgium	CHIREC Delta Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
matthieu clanet

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Morphine consumption	total morphine consumption from the PACU arrival to the 24 h post-surgery	24 hours after surgery
Secondary	Visual analog scale		Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Secondary	Morphine consumption		Post Anesthesia Care Unit admission (Hour 0), Hour +4
Secondary	Quality of Recovery 40 score	Recovery scale: From 40 (worst recovery) to 200 (Best Recovery)	operative Day -1, Operative day +1, operative day +30
Secondary	Hypoxemia	SpO2 < 90% on 2 liters of nasal Oxygen	up to patient discharge
Secondary	Postoperative Nausea and vomiting		Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Secondary	Need of Antiemetics		Up to patient discharge
Secondary	Bradycardia and use of atropine		Up to patient discharge
Secondary	Readmissions rate	Admission of the patient in hospital during the first 30 postoperative days	Up to 30 days