Post Operative Analgesia, Post Operative Nausea and Vomiting (PONV), Post Operative Recovery
Conditions
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
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
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.
DRUGOpioid-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 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Postoperative Nausea and Vomiting (PONV) | Within the first 24 hours postoperative. | Assessment of the incidence and severity of postoperative nausea and vomiting using a standardized PONV severity score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | At 0, 1, 6, and 12 hours postoperative. | Assessment of postoperative pain using the Visual Analogue Scale (VAS). minimum better score 0 maximum worse score 10. |
| Time to First Rescue Analgesia | Within the first 24 hours postoperative. | Time elapsed from the end of surgery until the patient requires the first rescue analgesic. |
| Total Postoperative Opioid Consumption | Within the first 24 hours postoperative . | Total amount of rescue opioid analgesics administered after surgery. |
| Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room ) | perioperative | 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 . |
| Prioperative Hemodynamic Parameters | Intraoperatively and during the immediate postoperative period. | Assessment of heart rate changes during and after surgery. |
| Serum Interleukin-6 (IL-6) Levels | Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia. | Measurement of serum IL-6 concentration as a biomarker of the perioperative stress response. |
| Opioid-Related Adverse Events | Within the first 24 hours postoperative. | Incidence of opioid-related complications, including postoperative hypoxemia. |
Countries
Egypt
Contacts
CONTACTyomna emad Youssef, MBBCH
CONTACTyomna emad youssef, MBBCH
PRINCIPAL_INVESTIGATORyomna Emad Youssef
Ainshams University Hospitals
Outcome results
None listed