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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl-Based Anesthesia, Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine).
- Who it may be relevant to
- Registry conditions: Post Operative Recovery, Post Operative Nausea and Vomiting (PONV), Post Operative Analgesia. Basic parameters: 40 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
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 s - 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 r
Primary outcome measures
- Incidence and Severity of Postoperative Nausea and Vomiting (PONV) [Time frame: Within the first 24 hours postoperative.]
Secondary outcome measures (7)
- Postoperative Pain Score [Time frame: At 0, 1, 6, and 12 hours postoperative.]
- Time to First Rescue Analgesia [Time frame: Within the first 24 hours postoperative.]
- Total Postoperative Opioid Consumption [Time frame: Within the first 24 hours postoperative .]
- Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room ) [Time frame: perioperative]
- Prioperative Hemodynamic Parameters [Time frame: 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.]
- Opioid-Related Adverse Events [Time frame: Within the first 24 hours postoperative.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams — Cairo
Identifiers
NCT: NCT07739641 · FMASU MD320/2025