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临床试验/CTRI/2018/05/014228
CTRI/2018/05/014228已完成Unknown

“DEXMEDETOMIDINE FOR THE PREVENTION OF HAEMODYNAMIC RESPONSE TO EXTUBATION IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA– PROSPECTIVE, RANDOMIZED STUDY.â€

INDRAPRASTHA APOLLO HOSPITAL NEW DELHI1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年6月12日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
1.Prevention of rise in blood pressure and heart rate by more than 15% of baseline after injection of Dexmedetomidine 0.50 micro gram per Kg body weight 10 minutes prior to extubation.

研究概览

简要总结

Laryngoscopy as well as tracheal intubation in patients undergoing surgery causes significant changes in hemodynamics . A similar type of hemodynamic derangement has been noticed by various workers during tracheal extubation. Various studies have been done on attenuation of extubation response using various drugs. The aim of the study is to define the role of dexmedetomidine with two different doses on attenuation of extubation stress response and hemodynamic changes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18 – 65yrs
  • Either sex.
  • Elective cases undergoing abdominal surgeries lasting more than one hour.
  • ASA I & ASA II.

排除标准

  • Patient’s refusal to take part in our study.
  • Patient on beta blockers or alpha blockers.
  • Patient requiring epidurals for post-operative pain relief.
  • Pregnant women.
  • Patients with BMI more than 33, those with history of drug abuse or psychological disorder and obese patients, with difficult airway or history of sleep apnoea.
  • Age <18 years and >65 years.

结局指标

主要结局

1.Prevention of rise in blood pressure and heart rate by more than 15% of baseline after injection of Dexmedetomidine 0.50 micro gram per Kg body weight 10 minutes prior to extubation.

时间窗: 2 hour

2.Prevention of rise in blood pressure and heart rate by more than 15% of baseline after injection of Dexmedetomidine 0.25 micro gram per Kg body weight 10 minutes prior to extubation.

时间窗: 2 hour

次要结局

  • EXTUBATION TIME(SEDATION SCORE)

研究者

发起方
INDRAPRASTHA APOLLO HOSPITAL NEW DELHI
申办方类型
Research institution and hospital

研究点 (1)

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