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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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-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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Opioid-Based Anaesthesia (OBA)Active comparator 1 intervention
Group B: Opioid-Free Anaesthesia (OFA) GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Within the first 24 hours postoperative.

Secondary outcomes

1

Postoperative Pain Score

Assessment of postoperative pain using the Visual Analogue Scale (VAS). minimum better score 0 maximum worse score 10.

Time frame
At 0, 1, 6, and 12 hours postoperative.
2

Time to First Rescue Analgesia

Time elapsed from the end of surgery until the patient requires the first rescue analgesic.

Time frame
Within the first 24 hours postoperative.
3

Total Postoperative Opioid Consumption

Total amount of rescue opioid analgesics administered after surgery.

Time frame
Within the first 24 hours postoperative .
4

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 .

Time frame
perioperative

Other outcomes

Sponsors and contacts

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