About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Undergoing a scheduled laparoscopic hysterectomy surgery under general anaesthesia.
Age group: 40-65 years old.
BMI<35.
ASA I-II.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Fentanyl-Based Anesthesia
DrugFentanyl 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)
DrugDexmedetomidine: 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Postoperative Pain Score
Assessment of postoperative pain using the Visual Analogue Scale (VAS). minimum better score 0 maximum worse score 10.
Time to First Rescue Analgesia
Time elapsed from the end of surgery until the patient requires the first rescue analgesic.
Total Postoperative Opioid Consumption
Total amount of rescue opioid analgesics administered after surgery.
Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room )
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 .
Sponsors and contacts
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