Comparison of opioid-free anaesthesia versus opioid based anaesthesia for quality of recovery after endoscopic sinus surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- comparison of postoperative quality of recovery score in
研究概览
简要总结
A total of 70 patients undergoing endoscopic sinus surgery will be randomly allocated to two groups of 35 patients each using computer generated random number table and the allotted number will be secured in a coded opaque sealed envelope.
The patients will be allocated to one of the following two groups: Group OFA (n=35): Patients will be given opioid-free anaesthesia. Group OBA (n=35): Patients will be given opioid-based anaesthesia.
Procedure on the day of surgery:
Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, continuous electrocardiogram, arterial oxygen saturation (Spo2) and end-tidal CO2 (EtCO2) will be done. All baseline parameters will be recorded.
Before the induction of anaesthesia, the patients in the OFA group will receive intravenous dexmedetomidine bolus of 1 mcg/kg (diluted to 20 ml normal saline) in infusion over 10min, followed by lidocaine bolus of 1.0 mg/kg (diluted to 5ml of normal saline). Patients in the OBA group will receive intravenous fentanyl bolus of 1.5 mcg/kg (diluted to 20 ml normal saline) in infusion over 10 min followed by normal saline bolus of 5 ml.
During maintenance of anaesthesia, the OFA group will receive a continuous intravenous infusion of dexmedetomidine 0.3mcg/kg/hr (diluted to 50 ml of normal saline) and intravenous infusion of lidocaine 1.5mg/kg/h (diluted to 50 ml of normal saline) with sevoflurane (1% to 3%), whereas the OBA group will receive a continuous intravenous infusion of fentanyl 0.5 mcg/kg/hr (diluted to 50 ml of normal saline) and 50 ml of normal saline infusion as placebo with sevoflurane (1% to 3%).
The pain will be evaluated by using VAS score at 30 min, 1 h, 2 h, 6 h and 24 h which will be evaluated both at rest and on coughing. Quality of recovery score will be assessed at 24 hours after surgery using 15 item QoR questionnaire. The Ramsay Sedation Score will be evaluated every 15 min till the discharge of the patient from PACU. Time from PACU discharge will be noted.
Patient will be monitored continuously intra and post operatively and observations will be recorded in the prescribed proforma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 years to 65 years Patients undergoing endoscopic sinus surgery American Society of Anaesthesiologists (ASA) Grade I and II Body Mass Index (BMI) more than 18 and less than 35 kg/m2.
排除标准
- •Patients with coagulopathy and platelet disorders.
- •Contraindication or allergy to study drugs Pregnant and lactating women Severe cardiovascular, respiratory, neurological or metabolic disease Psychological inability of the patient to understand the QoR 15 questionnaire.
- •Patients with baseline heart rate less than 60 beats/ minute.
结局指标
主要结局
comparison of postoperative quality of recovery score in
时间窗: 24 hours post-operatively
patients receiving opioid based anaesthesia vs. opioid free anaesthesia in endoscopic sinus surgery
时间窗: 24 hours post-operatively
次要结局
- To compare the post operative pain score(30 min, 1 hours, 2 hours, 6 hours after surgery)
- To compare the postoperative Ramsay sedation score in post anaesthesia care unit(15 min, 30 min, 45 min, 1 hours after surgery)
- To compare the time of discharge from post anaesthesia care unit(1 to 2 hour)
研究者
Amrita Singh
Government Medical College and Hospital, Chandigarh