N/A
Completed N=60
Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
Morbid Obesity · Postoperative Pain · Opioid Free Anesthesia · Bariatric Surgery
Source: ClinicalTrials.gov NCT07337135 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) — 2.5; 0; 3; 1 Score on a scale (0-10)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS) |
2.5; 0; 3; 1; 3; 1 | — |
| SECONDARY Intraoperative Nociception (NOL Index) |
5; 11; 7; 2; 6; 12 | — |
| SECONDARY Need for Rescue Analgesia |
22; 9; 8; 21 | — |
| SECONDARY Opioid Consumption |
21; 8; 1; 1 | — |
| SECONDARY Incidence of Postoperative Nausea and Vomiting (PONV) |
22; 22; 3; 4; 4; 3 | — |
| SECONDARY Need for PONV Treatment |
4; 5; 26; 25 | — |
| SECONDARY Patient Satisfaction |
9.2; 9.5 | — |
| SECONDARY Postoperative Complications |
0; 0; 30; 30 | — |
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.
Data sourced from ClinicalTrials.gov (NCT07337135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.