drugset / Trial / NCT07337135

Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery

NCT07337135

Completed 60 enrolled Hospital dos Lusíadas
RandomizedParallel-groupOpen-labelTreatment

Summary

This prospective randomized controlled trial aims to compare the clinical effectiveness and safety of opioid-free anesthesia (OFA) versus traditional opioid-based anesthesia (OBA) in adult patients undergoing laparoscopic bariatric surgery. The study evaluates postoperative pain, need for rescue analgesia, incidence of postoperative nausea and vomiting (PONV), intraoperative nociception monitoring (NOL index), and patient satisfaction. A total of 60 patients were randomized into two parallel groups receiving either OFA or OBA according to standardized anesthetic protocols.

Timeline

Start
2023-10-02
Primary completion
2024-04-19
Completion
2024-04-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 50 ug
Subject Ketamine Small molecule 50 mg
Subject Lidocaine Other / unclassified 500 mg
Comparator Remifentanil Small molecule 2 mg
Background Acetaminophen Small molecule
Background Cefazolin Small molecule
Background Desflurane Other / unclassified
Background Dexamethasone Small molecule 4 mg
Background Dexamethasone Small molecule 8 mg
Background Dexamethasone Small molecule
Background Esomeprazole Small molecule
Background Ketorolac Other / unclassified
Background Metamizole Unknown
Comparator Morphine Other / unclassified
Background Parecoxib Small molecule
Background Propofol Small molecule
Background Rocuronium Other / unclassified
Background Tramadol Other / unclassified 100 mg
Background Tramadol Other / unclassified

Indications