drugset / Trial / NCT07337135
Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |