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

NCT07787858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-26

No results posted yet for this study

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.

Conditions

  • Postoperative Pain Intensity

Interventions

COMBINATION_PRODUCT

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.

DRUG

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.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Dr Asmaa Mohamed Galal Eldin, Assist Prof · faculty of medicine zagazig university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-07-16
Completion
2026-07-16

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787858 on ClinicalTrials.gov