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
| Type | Name | Description |
|---|---|---|
| DRUG | Dexmedetomidine Injection [Precedex] | dexmedetomidine or remifentanil during laparoscopic gastric bypass |
| DRUG | Remifentanil | dexmedetomidine 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.