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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-07-31

No results posted yet for this 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

Conditions

  • Post Operative Recovery
  • Post Operative Nausea and Vomiting (PONV)
  • Post Operative Analgesia

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • yomna Emad Youssef · Ainshams University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-22
Primary Completion
2027-02-15
Completion
2027-04-20

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 NCT07739641 on ClinicalTrials.gov