跳至主要内容
临床试验/CTRI/2019/03/018007
CTRI/2019/03/018007尚未招募不适用

A randomized control trial to compare the efficacy of dexmedetomidine and labetalol for induced hypotensive anaesthesia in ear, nose and throat surgeries

Robin Sajan Chacko1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年12月3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
58
试验地点
1
主要终点
To compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline.

研究概览

简要总结

This is a randomized controlled trial to compare the efficacy of dexmedetomidine and labetalol for producing induced hypotensive anaesthesia in 58 patients posted for ear nose throat surgeries over a period of 18 months. The primary outcome would be to compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline. The secondary objectives are to compare surgeon’s satisfaction of surgical field between the study drugs, to compare total blood loss occurring during surgery between the study drugs and to compare recovery time between the study drugs.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • 1.Patients of either sex undergoing elective ENT surgeries under general anaesthesia
  • American Society of Anaesthesiologists I or II
  • BMI between 18.5 and 24.9 kg/m2.

排除标准

  • American Society of Anaesthesiologists III and above
  • Allergic to study drugs.
  • Asthmatic patients.
  • Patients having coagulopathy.
  • Patients with heart blocks.
  • Lactating mothers and pregnant patients.
  • Hepatic or renal abnormality.
  • Patients with congestive cardiac failure, bradycardia.
  • Hypertensive patients.
  • Patients using beta blockers.

结局指标

主要结局

To compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline.

时间窗: Intraoperative Period

次要结局

  • To compare surgeon’s satisfaction of surgical field between the study drugs.(Intraoperative period)
  • To compare total blood loss occurring during surgery between the study drugs.(Intraoperative period)
  • To compare recovery time between the study drugs.(Postoperative period)

研究者

发起方
Robin Sajan Chacko
申办方类型
Other [self]

研究点 (1)

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