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

July 27, 2026 updated by: Ain Shams University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective randomised controlled study aims to evaluate the effects of opioid-free anaesthesia (OFA) compared with conventional opioid-based anaesthesia (OBA) in adult patients undergoing elective surgery under general anaesthesia. Eligible patients will be randomly assigned into two equal groups. The OFA group will receive a multi modal opioid-free anaesthetic regimen consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous infusions. The OBA group will receive fentanyl-based anaesthesia according to a standardised protocol. Both groups will receive similar induction agents, muscle relaxants, anti emetic prophylaxis, and postoperative analgesic regimens.

Preoperative hemodynamic parameters, including heart rate and blood pressure, will be recorded intraoperatively and during the postoperative period. Postoperative recovery will be assessed using the SAMPE recovery room discharge checklist(Stability, Awake and Oriented, Motor, Pain, and Emesis) recovery room discharge checklist, an eight-item score assessing vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block. Patients will be discharged from the post-anaesthesia care unit (PACU) upon achieving a SAMPE score of 8.. Pain intensity will be evaluated using the Visual Analogue Scale (VAS) at predetermined postoperative time points (0, 1, 6, and 12 hours). The incidence and severity of postoperative nausea and vomiting (PONV) during the first 24 postoperative hours will be recorded and graded using a standardised PONV severity score. Additional outcomes include time to first rescue analgesia, total postoperative opioid consumption, and the occurrence of opioid-related adverse events such as postoperative hypoxemia.

Furthermore, serum interleukin-6 (IL-6) levels will be measured preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia as a biomarker of the surgical stress response. The study seeks to determine whether opioid-free anaesthesia can improve postoperative recovery, reduce PONV and opioid requirements, and attenuate the preoperative stress response compared with conventional opioid-based anaesthesia.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 00202
        • Ain Shams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opioid-Based Anaesthesia (OBA)
Participants will receive conventional fentanyl-based anaesthesia during surgery in addition to standardized general anaesthesia.
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.
Active Comparator: Opioid-Free Anaesthesia (OFA) Group
Participants will receive opioid-free anaesthesia consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous intravenous infusions during surgery, in addition to standardized general anaesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Postoperative Nausea and Vomiting (PONV)
Time Frame: Within the first 24 hours postoperative.
Assessment of the incidence and severity of postoperative nausea and vomiting using a standardized PONV severity score.
Within the first 24 hours postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: At 0, 1, 6, and 12 hours postoperative.
Assessment of postoperative pain using the Visual Analogue Scale (VAS). minimum better score 0 maximum worse score 10.
At 0, 1, 6, and 12 hours postoperative.
Time to First Rescue Analgesia
Time Frame: Within the first 24 hours postoperative.
Time elapsed from the end of surgery until the patient requires the first rescue analgesic.
Within the first 24 hours postoperative.
Total Postoperative Opioid Consumption
Time Frame: Within the first 24 hours postoperative .
Total amount of rescue opioid analgesics administered after surgery.
Within the first 24 hours postoperative .
Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room )
Time Frame: perioperative
Assessment of recovery using the SAMPE(score of ambulatory patients in the recovery room ) discharge checklist evaluating vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block minimum worse score 0 maximum better score 8 .
perioperative
Prioperative Hemodynamic Parameters
Time Frame: Intraoperatively and during the immediate postoperative period.
Assessment of heart rate changes during and after surgery.
Intraoperatively and during the immediate postoperative period.
Serum Interleukin-6 (IL-6) Levels
Time Frame: Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.
Measurement of serum IL-6 concentration as a biomarker of the perioperative stress response.
Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.
Opioid-Related Adverse Events
Time Frame: Within the first 24 hours postoperative.
Incidence of opioid-related complications, including postoperative hypoxemia.
Within the first 24 hours postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: yomna Emad Youssef, Ainshams University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 22, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

July 5, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD320/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe