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临床试验/CTRI/2018/02/012009
CTRI/2018/02/012009已完成不适用

Effect of Dexmedetomidine on induction and hemodynamic response to laryngoscopy and intubation with Propofol and Sevoflurane

未提供1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月26日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Primary objective:

研究概览

简要总结

There are many studies on dexmedetomidine forattenuation of stress response during laryngoscopy and intubation, but none ofthe studies evaluate the effect of dexmedetomidine with different inductionagents. This study aims to evaluate the effect of dexmedetomidine on inductionwith respect to hemodynamic response,dose  required and smoothness of induction also toevaluate the combined effect of dexmedetomidine with propofol and sevofluraneon cardiovascular response to laryngoscopy and intubation.

研究设计

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

入排标准

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

入选标准

  • 1.ASA I or II (no or minimal co-morbid disease) 2.Patients scheduled for elective surgeries.

排除标准

  • 1.History of allergy or contraindications study drug 2.Concomitant use of medications which may exaggerate the heart rate response of Dexmedetomidine including digoxin or β-adrenergic antagonists.
  • 3.Predicted difficulty in intubation, 4.pregnant patients 5.nursing women 6.morbid obesity 7.Coronary artery disease 8.ischemic heart disease 9.heart blocks.

结局指标

主要结局

Primary objective:

时间窗: 1. 5min after settling in OT | 2. 2 min after administration of drug, | 3.1min after induction and | 4.at 1, 3, 5 and 10 min after intubation

1.To compare the Mean Arterial Pressure and Heart Rate response to induction with Propofol and Sevoflurane after dexmedetomidine 1ï­g/kg IV infusion.

时间窗: 1. 5min after settling in OT | 2. 2 min after administration of drug, | 3.1min after induction and | 4.at 1, 3, 5 and 10 min after intubation

2.To compare effectiveness of Dexmedetomidine 1ï­g/kg with propofol and Dexmedetomidine 1ï­g/kg with sevoflurane in attenuating cardiovascular response during laryngoscopy and intubation

时间窗: 1. 5min after settling in OT | 2. 2 min after administration of drug, | 3.1min after induction and | 4.at 1, 3, 5 and 10 min after intubation

次要结局

  • Secondary objective: To compare time of induction and smoothness of induction(The time of start of injection of propofol or mask placement with sevoflurane 8% was considered as ‘starting point of induction’. The patients were asked every 5 seconds, to open the eyes and loss of response to this command was defined as loss of verbal contact. Eyelash reflex will be then checked for additional confirmation of loss of consciousness which is defined as ‘induction end point’. The time taken for anesthetic induction will be recorded for both groups)

研究者

发起方
未提供

研究点 (1)

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