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临床试验/CTRI/2021/12/038697
CTRI/2021/12/038697尚未招募不适用

Effect of opioid free and opioid anaesthesia on postoperative recovery in patients undergoing laparoscopic cholecystectomy.

Department of Anaesthesiology and Intensive Care1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Difference in postoperative recovery using QoR-40 score 24 hours after surgery.

研究概览

简要总结

Opioid free anaesthesia is an anaesthetic technique where opioids are not used in the intraoperative period, by either systemic, neuraxial or intracavitary route. By avoiding the use of opioids in the perioperative period, the number of opioid related side effects are reduced.

Recently, multimodal analgesia techniques are becoming the basis of successful fast track surgery. These multidrug regimens aim at decreasing postoperative pain and intraoperative and postoperative opioid related adverse effects, thus hastening recovery. A multimodal approach allows reduction of the dose of each individual  drug and exploits the synergistic effect among drugs, thereby reducing their side effect.

Thus, we decided to compare the effect of opioid free and opioid anaesthesia on postoperative recovery in patients undergoing laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) Physical Status Grade I-II.

排除标准

  • 1.Patients with AV block or severe bradycardia 2.Patients having BMI >30 kg/m2 3.Patients with allergy to any of the study drugs 4.Patients with cardiac, renal, hepatic and psychiatric illness.
  • 5.H/o chronic use of opioid analgesic/ chronic steroids/ NSAIDS/ or any chronic drug therapy 6.H/o alcohol abuse 7.Patients who are pregnant or are breastfeeding 8.Patients with decreased autonomic control- elderly, diabetic, chronic hypertension, severe cardiac disease, on drugs like beta blockers or calcium channel blockers 9.Patient refusal.

结局指标

主要结局

Difference in postoperative recovery using QoR-40 score 24 hours after surgery.

时间窗: 24 hours after surgery.

次要结局

  • Postoperative VAS scores
  • Requirement of postoperative analgesics in the first 24 hours after surgery(over first 24 hours after surgery)
  • Any intraoperative bradycardia, hypotension, tachycardia, or hypertension(at any point of time intraoperatively)
  • Sedation score in PACU(on arrival at Post Aanaesthesia Care Unit (PACU))
  • Time for readiness for discharge from PACU (PADSS score)(0 min, 15 mins, 30 mins, 45 mins, 60 mins, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours in PACU)
  • Postoperative opioid related side effects(within 24 hours of postoperative period)

研究者

发起方
Department of Anaesthesiology and Intensive Care
申办方类型
Government medical college

研究点 (1)

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