Analgesics, Opioid
Conditions
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.
Interventions
DRUGDexmedetomidine Injection [Precedex]
dexmedetomidine or remifentanil during laparoscopic gastric bypass
DRUGRemifentanil
dexmedetomidine or remifentanil during laparoscopic gastric bypass
Sponsors
matthieu clanet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Morphine consumption | 24 hours after surgery | total morphine consumption from the PACU arrival to the 24 h post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | Post Anesthesia Care Unit admission (Hour 0), Hour +4 | — |
| Quality of Recovery 40 score | operative Day -1, Operative day +1, operative day +30 | Recovery scale: From 40 (worst recovery) to 200 (Best Recovery) |
| Hypoxemia | up to patient discharge | SpO2 \< 90% on 2 liters of nasal Oxygen |
| Visual analog scale | Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24 | — |
| Need of Antiemetics | Up to patient discharge | — |
| Bradycardia and use of atropine | Up to patient discharge | — |
| Readmissions rate | Up to 30 days | Admission of the patient in hospital during the first 30 postoperative days |
| Postoperative Nausea and vomiting | Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24 | — |
Countries
Belgium
Outcome results
None listed