跳至主要内容
临床试验/CTRI/2018/05/014233
CTRI/2018/05/014233已完成Phase 3 4

Comparative evaluation of dexmedetomidine and fentanyl in total intravenous anaesthesia for laparoscopic cholecystectomy

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月1日最近更新:

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

申办方类型
Government medical college

研究点 (1)

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