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

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.

• Postoperative Pain Score [Срок оценки: At 0, 1, 6, and 12 hours postoperative.]
• Time to First Rescue Analgesia [Срок оценки: Within the first 24 hours postoperative.]
• Total Postoperative Opioid Consumption [Срок оценки: Within the first 24 hours postoperative .]
• Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room ) [Срок оценки: perioperative]
• Prioperative Hemodynamic Parameters [Срок оценки: Intraoperatively and during the immediate postoperative period.]
• Serum Interleukin-6 (IL-6) Levels [Срок оценки: Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.]
• Opioid-Related Adverse Events [Срок оценки: Within the first 24 hours postoperative.]