NCT07337135

Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery

Opioid-free Anesthesia vs Opioid-based Anesthesia / A Heavyweight Showdown - Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital dos Lusíadas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bariatric surgery is the most effective treatment for severe and morbid obesity, but perioperative pain management and PONV remain significant challenges. Traditional opioid-based anesthesia is associated with adverse effects such as respiratory depression, postoperative hyperalgesia, ileus, and delayed recovery. Opioid-free anesthesia is an emerging strategy based on the use of multimodal, non-opioid agents-including dexmedetomidine, lidocaine, and ketamine-aimed at providing adequate analgesia while reducing opioid-related complications. This randomized controlled trial evaluates whether OFA improves postoperative pain control, reduces the requirement for rescue analgesia, and promotes better perioperative outcomes compared to OBA in laparoscopic bariatric surgery. Outcomes include NRS pain scores at multiple time points, NOL monitoring during surgery, PONV occurrence, and patient satisfaction at discharge.

Conditions

• Morbid Obesity
• Postoperative Pain
• Opioid Free Anesthesia
• Bariatric Surgery

Interventions

Type	Name	Description
DRUG	Opioid-Based Anesthesia (Remifentanil-Based Protocol)	Participants receive standard opioid-based general anesthesia consisting of: * Continuous remifentanil infusion (2 mg diluted in 40 mL saline), * Propofol for induction, * Rocuronium for neuromuscular blockade, * Desflurane for maintenance, * Dexamethasone 4-8 mg for PONV prophylaxis, * Cefazolin for antibiotic prophylaxis, * Esomeprazole for stress-ulcer prevention. Postoperative analgesia includes paracetamol + ketorolac/parecoxib + metamizole, with tramadol and/or morphine provided as rescue. NOL, BIS, TOF, and standard monitoring are used.
DRUG	Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)	Participants receive opioid-free anesthesia consisting of: * Dexmedetomidine bolus (15-20 μg), * Continuous infusion of dexmedetomidine 50 μg + ketamine 50 mg + lidocaine 500 mg in 50 mL saline (rate: 1 mL/10 kg), * Propofol for induction, * Rocuronium for neuromuscular blockade, * Desflurane for maintenance, * Dexamethasone for PONV prophylaxis, * Cefazolin and esomeprazole for prophylaxis. * The analgesic infusion is reduced by half 30 min before end of surgery and continued for 1 hour in PACU. Postoperative analgesia includes paracetamol + ketorolac/parecoxib + metamizole, with tramadol 100 mg as rescue. Monitoring includes NOL, BIS, TOF.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-04-19
• Completion: 2024-04-21
• First posted: 2026-01-13
• Last updated: 2026-02-25
• Results posted: 2026-02-25

Locations

1 site across 1 country: Portugal