CompletedN/Aketamine
Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
Sponsored by Hospital dos Lusíadas
NCT ID
NCT07337135
Target Enrollment
60 participants
Start Date
2023-10-02
Est. Completion
2024-04-21
About This Study
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.
Conditions Studied
Interventions
- •Opioid-Based Anesthesia (Remifentanil-Based Protocol)
- •Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Age ≥ 18 years; * Body mass index (BMI ≥ 35 kg/m² with associated comorbidities) or BMI ≥ 40 kg/m²; * Scheduled for elective laparoscopic bariatric surgery; * Ability to provide informed consent. Exclusion Criteria: * Pregnancy; * History of substance abuse; * Severe psychiatric disease; * Contraindications to any of the drugs used in either anesthetic protocol (dexmedetomidine, ketamine, lidocaine, remifentanil, etc.); * Inability to comply with study procedures; * Refusal or inability to provide informed consent.
Study Locations (1)
Hospital Lusíadas Amadora - Lusíadas Saúde, S.A.
Amadora, Portugal