At a glance
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Opioid-free Anesthesia vs Opioid-based Anesthesia / A Heavyweight Showdown - Randomized Controlled Trial
In Brief
A clinical study evaluating Opioid-Based Anesthesia (Remifentanil-Based Protocol) and Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol) for Morbid Obesity and 3 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.