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临床试验/CTRI/2021/07/034887
CTRI/2021/07/034887招募中不适用

Bispectral index guided comparison of Dexmedetomidine and Fentanyl premedication for time required to achieve adequate depth for endotracheal intubation– A Prospective Double Blind Randomised Control Trial

Mohammad Faseehullah Alam1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年7月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
To assess the time required to achieve adequate BIS for endotracheal intubation.

研究概览

简要总结

The BIS monitor, derived from electroencephalogram (EEG) data, has been used as a statistical predictor of the level of hypnosis and has been proposed as a tool to reduce the risk of intraoperative awareness. Bispectral index (BIS) is a widely used quantitative parameter for evaluating depth of anesthesia and sedation.

Fentanyl and dexmedetomidine has potent sedative properties. They have been used as an anesthetic sparing agent but not as a sole anesthetic agent as premedication. In view of above facts, this study aims to assess the time required to achieve adequate depth for intubation, using Bispectral index as guide.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 50 years of both sex undergoing elective surgery under general anaesthesia.
  • ASA 1 and
  • Consenting patients.

排除标准

  • Patient refusal 2)ASA 3 & 4 3) History of Allergy.

结局指标

主要结局

To assess the time required to achieve adequate BIS for endotracheal intubation.

时间窗: 3 minutes if desired BIS is achieved. Maximum waiting period will be for 6 minutes, after that rescue drug injection propofol in 1mg/kg will be repeated.

次要结局

  • To compare haemodynamic between both the groups.(Total amount of rescue drug required to achieve the desired BIS.)

研究者

发起方
Mohammad Faseehullah Alam
申办方类型
Other [self]

研究点 (1)

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