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临床试验/CTRI/2018/05/013896
CTRI/2018/05/013896已完成3 期

EFFICACY OF I.V CLONIDINE OR DEXMEDETOMIDINE AS PREMEDICATION FOR CONTROLLING BLOOD LOSS IN PATIENTS UNDERGOING SEPTOPLASTY AND FESS UNDER GENERAL ANAESTHESIA

SDM college of medical science and hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年3月10日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
90
试验地点
1
主要终点
To assess change in haematocrit during the intraoperative period

研究概览

简要总结

This study was conducted in SDM college of medical science and hospital by Dr Mithun B Shetty as a part of his dissertation study and was completed

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator 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 PS 1 or ASA PS 2, undergoing Septoplasty and FESS
  • Willing to participate.

排除标准

  • ASA PS >3
  • Basal heart rate < 60 bpm
  • Pregnant women
  • Lactating mother
  • Hepatic, Renal or Cardiac abnormalities
  • Known case of coagulopathy
  • Allergic to Dexmedetomidine or Clonidine
  • Psychiatric disorder or Cognitive delay
  • Refusal to participate.

结局指标

主要结局

To assess change in haematocrit during the intraoperative period

时间窗: To assess change in haematocrit during the intraoperative period by calculating pre-op, post-op and suction jar Hb/PCV

次要结局

  • Heart rate variability(Baseline, before & after premedication, prior induction, after intubation, 5,10,15,30,45,60,75,90,105,120,135,150,165,180 minutes after incision)
  • Amount of Fentanyl used peri-operatively(Total usage, calculated at the end of the surgery)
  • Surgical field assessment(End of surgery)
  • Surgeon satisfaction score(End of surgery)

研究者

申办方类型
Private medical college

研究点 (1)

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