CTRI/2018/05/014233已完成Phase 3 4
Comparative evaluation of dexmedetomidine and fentanyl in total intravenous anaesthesia for laparoscopic cholecystectomy
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- time to Post anaesthesia discharge score(PADSS) ≥ 9
研究概览
简要总结
Comaparative evaluation in the efficacy of dexmedetomidine and fentanyl in total intravenous anaesthesia for laparoscopic cholecystectomies regarding post anaesthesia discarge score, intraoperative hemodynamics, on table recovery time, total propofol consumption, number of patients requiring rescue analgesia, time to rescue analgesia, number of patients requiring rescue antiemetic
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Grade 1 and 2.
排除标准
- •ASA grade 3 and 4 Duration of surgery more than 1.5 hours BMI more than equal to 30 patient on anti-hypertensive medication anticipated difficult airway history of substance abuse or patient on psychotropic drugs history suggestive of allergy to inj propofol or to other drugs under study.
结局指标
主要结局
time to Post anaesthesia discharge score(PADSS) ≥ 9
时间窗: assessment every 10 minutes in post operative period
次要结局
- intraoperative hemodynamics(intraoperative)
- total propofol consumption(intraoperative)
- on table recovery time(time taken from stopping of propofol infusion till the time patient responds to verbal command)
- number of patients requiring rescue analgesia(postoperative)
- time to rescue analgesia(time between admission to PACU and first postoperative analgesic requirement)
- number of patients requiring rescue antiemetic(postoperative)
研究者
研究点 (1)
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