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临床试验/CTRI/2017/11/010355
CTRI/2017/11/010355进行中(未招募)4 期

The comparison of the effects of dexmedetomidine, esmolol and combination of dexmedetomidine with esmolol to attenuatehemodynamic response to endotracheal intubation in patientsundergoing CABG.

Vydehi Institute of Medical Sciences and Research Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月7日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
attenuation of stress response to endotracheal intubation in terms of heart rate, blood pressure and pulmonary artery pressure

研究概览

简要总结

***Background and objectives:***Laryngoscopy and intubation can cause hemodynamicresponse. Various medications may be employed to control that response. In thisstudy, we aim to compare the effects of dexmedetomidine, esmolol and esmololwith dexmedetomidine on hemodynamic response.

 ***Methods:***Hundredand twenty elective surgery patients in need of endotracheal intubation, who wereAmerican Society of Anesthesiology I - II group and ages between 21 and 65years were included in a prospective, randomized, double-blind study. Systolic,diastolic, mean arterial & pulmonary pressures, heart rates, at the time ofadmittance to the operation room were recorded as basal measurements. Thepatients were randomized into four groups: Group I (n = 30) received 1 µg/kgdexmedetomidine, Group II (n = 30) received 2 mg/kg esmolol, Group III (n= 30) received 0.5 µg/kg dexmedetomidine plus 1 mg/kg esmolol and Group IV (n= 30) received 1µg/kg dexmedetomidine plus 2mg/kg esmolol with infusionover a period of 10 min before induction. The patients were intubated 2 min afterinduction. Systolic, diastolic, mean arterial & pulmonary pressures andheart rates were measured at base line, 10 minutes after drug, 2 min afterinduction before intubation and 1, 3, 5, min after intubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • Adult patients with ASA 1and 2 physical status scheduled for cardiac surgery.

排除标准

  • Exclusion criteria included anticipated difficult intubation, emergency surgery, left ventricular ejection fraction <40%, left ventricular aneurysm, associated valvular lesions, left main coronary artery disease, severe systemic diseases involving the renal and hepatic systems, preoperative left bundle branch block, chronic obstructive pulmonary disease and intubation attempt lasting longer than 20 seconds.

结局指标

主要结局

attenuation of stress response to endotracheal intubation in terms of heart rate, blood pressure and pulmonary artery pressure

时间窗: Hemodynamic variables(heart rate,blood pressure and pulmonary pressure) were recorded baseline, after study drug, after induction before intubation and 1, 3, 5 minute after orotracheal intubation.

次要结局

未报告次要终点

研究者

发起方
Vydehi Institute of Medical Sciences and Research Centre
申办方类型
Private medical college

研究点 (1)

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