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Effect of Opioid-Free Versus Opioid-Based Anesthesia in Discectomy Surgery
Sponsor: Zagazig University
Summary
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.
Official title: Effect of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Analgesia in Patients Undergoing Discectomy Surgery
Key Details
Gender
All
Age Range
21 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2026-01-15
Completion Date
2026-07-16
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine and Ketamine-based Opioid-free Anesthesia
Patients will receive: 1) Dexmedetomidine loading dose 1 µg/kg over 10 min, then infusion 0.2-0.7 µg/kg/hr; 2) Ketamine 0.25-0.5 mg/kg IV at induction, then infusion 0.1-0.3 mg/kg/hr; 3) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.
Fentanyl-based Opioid Anesthesia
Patients will receive: 1) Fentanyl 2 µg/kg IV at induction, followed by continuous infusion of 1 µg/kg/hr; 2) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.
Locations (1)
Zagazig University Hospitals
Zagazig, Egypt