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Clinical trial

Effect of Opioid-Free Versus Opioid-Based Anesthesia in Discectomy Surgery

Zagazig UniversityCompletedStarted Jan 15, 202646 enrolledEgyptNCT07787858

Abstract

This prospective randomized double-blind clinical trial compares opioid-free anesthesia (OFA) versus opioid-based anesthesia (OBA) on postoperative analgesia in patients undergoing elective lumbar discectomy surgeries at Zagazig University Hospitals. Forty-six adult patients (ASA I-II, aged 21-64) will be randomly allocated to two groups. Group F (OFA) receives dexmedetomidine (loading 1 µg/kg, infusion 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, infusion 0.1-0.3 mg/kg/hr). Group B (OBA) receives fentanyl (2 µg/kg bolus, 1 µg/kg/hr infusion). Both groups receive propofol maintenance. Primary outcome is postoperative pain intensity measured by Visual Analog Scale (0-10) at baseline, 2, 6, 12, and 24 hours. Secondary outcomes include total analgesic consumption in 24 hours, time to first rescue analgesia, intraoperative hemodynamic stability (BP, MAP, HR, RR), recovery time (to responsiveness), sedation depth (Modified Ramsay Score), PACU discharge time, patient satisfaction, and incidence of opioid-related adverse effects (nausea, vomiting, respiratory depression). The study hypothesizes that OFA provides comparable analgesia with fewer opioid-related complications. As the first such study at Zagazig University, it addresses the critical need for effective non-opioid pain management in spine surgery, contributing to safer practices amid global opioid concerns.

Topics & conditions

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KetaminePain

Keywords

Opioid-freeOpioid-baseddexmedetomidinefentanylPostoperative Pain Intensity

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