Clinical Trials Directory

Trials / Completed

CompletedNCT05004519

Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
183 (actual)
Sponsor
matthieu clanet · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidine Injection [Precedex]dexmedetomidine or remifentanil during laparoscopic gastric bypass
DRUGRemifentanildexmedetomidine or remifentanil during laparoscopic gastric bypass

Timeline

Start date
2021-10-05
Primary completion
2022-09-15
Completion
2022-10-15
First posted
2021-08-13
Last updated
2023-11-30

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT05004519. Inclusion in this directory is not an endorsement.