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 | Not Yet Recruiting DMC

• 1 other identifier: FMASU MD320/2025
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Postoperative Nausea and Vomiting (PONV)

  Assessment of the incidence and severity of postoperative nausea and vomiting using a standardized PONV severity score.

  Within the first 24 hours postoperative.

Secondary Outcomes (7)

• Postoperative Pain Score

  At 0, 1, 6, and 12 hours postoperative.

• Time to First Rescue Analgesia

  Within the first 24 hours postoperative.

• Total Postoperative Opioid Consumption

  Within the first 24 hours postoperative .

• Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room )

  perioperative

• Prioperative Hemodynamic Parameters

  Intraoperatively and during the immediate postoperative period.

Study Arms (2)

Opioid-Based Anaesthesia (OBA)

ACTIVE COMPARATOR

Participants will receive conventional fentanyl-based anaesthesia during surgery in addition to standardized general anaesthesia.

Drug: Fentanyl-Based Anesthesia

Opioid-Free Anaesthesia (OFA) Group

ACTIVE COMPARATOR

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)

Interventions

Fentanyl-Based Anesthesia DRUG

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-Based Anaesthesia (OBA)

Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine) DRUG

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.

Opioid-Free Anaesthesia (OFA) Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing a scheduled laparoscopic hysterectomy surgery under general anaesthesia.
• Age group: 40-65 years old.
• BMI\<35.
• ASA I-II.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams

Cairo, Abbasia, 00202, Egypt

Location

MeSH Terms

Conditions

Vomiting

Interventions

Dexmedetomidine; Ketamine; Lidocaine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• yomna Emad Youssef

  Ainshams University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yomna emad Youssef, MBBCH

CONTACT

01026616629; yomnaelsayed@med.asu.edu.eg

yomna emad youssef, MBBCH

CONTACT

01145211869; yomnayoussef95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 22, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

EG (1)