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Clinical Trials in Egypt / NCT07739641
Starting soon Not applicable

A COMPARATIVE STUDY BETWEEN OPIOID-FREE GENERAL ANAESTHESIA AND OPIOID-BASED GENERAL ANAESTHESIA ON THE QUALITY OF RECOVERY IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC HYSTRECTOMY: A Randomized Trial

NCT07739641 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-08-22
Last updated
2026-07-31

Condition(s) studied

Post Operative RecoveryPost Operative Nausea and Vomiting (PONV)Post Operative Analgesia

Investigational drug(s) / intervention(s)

Fentanyl-Based AnesthesiaOpioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)

Fentanyl-Based Anesthesia: Fentanyl will be administered intravenously as the opioid component of balanced general anaesthesia. Loading dose of 2 mic/kg I.V. followed by continuous infusion of three syringes, one with fentanyl infusion 0.5mic/kg/hr, and two syringes with normal saline. will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure. Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4.

Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine): Dexmedetomidine: Loading dose of 1 µg/kg IV over 10 min before induction, followed by continuous infusion at 0.4 µg/kg/h . Ketamine: Loading dose of 0.25mg/kg followed by continuous infusion of ketamine at 0.1mg/kg/hr . Lidocaine: loading dose of 1.5mg/kg/hr followed by maintainance of 1mg/kg/hr. All three infusions to be stopped 30 minutes before skin closure will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure. Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4.

Study summary

the intent of this study To compare the efficacy of opioid free general anaesthesia versus opioid based general anaesthesia to achieve enhanced recovery regarding post-operative pain and post-operative nausea and vomiting episodes in patients undergoing elective laparoscopic hysterectomy

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Undergoing a scheduled laparoscopic hysterectomy surgery under general anaesthesia. * Age group: 40-65 years old. * BMI\<35. * ASA I-II. Exclusion Criteria: * Emergency hysterectomy. * Allergy to any of the drugs used in the study. * HR \< 50 bpm (chronic treatment by beta blockers, heart block patients). * Alcohol or drug abuse. * Psychiatric disease. * Liver impairment. Kidney impairment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ain Shams Cairo Abbasia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07739641 on ClinicalTrials.gov ↗ ← All trials in Egypt