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
Verified date | November 2023 |
Source | Chirec |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | CHIREC Delta Hospital | Brussels |
Lead Sponsor | Collaborator |
---|---|
matthieu clanet |
Belgium,
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 |
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