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临床试验/CTRI/2021/08/035835
CTRI/2021/08/035835尚未招募4 期

COMPARATIVE STUDY OF EFFECTIVENESS OF INTRAVENOUS DEXMEDETOMIDINE VERSUS INTRANASAL DEXMEDETOMIDINE FOR ATTENUATION OF HEMODYNAMIC RESPONSES TO LARYNGOSCOPY,INTUBATION AND FIXATION OF SKULL PIN HOLDER IN PATIENTS UNDERGOING CRANIOTOMY: A RANDOMIZED CONTROLLED DOUBLE-BLIND STUDY

King George Mrdical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年8月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To compare mean arterial pressure

研究概览

简要总结

This study will compare Intravenous dexmedetomidine with intranasal dexmedetomidine for attenuation of hemodynamic response to laryngoscopy, intubation and fixation of skull pin holder in patient undergoing elective craniotomy

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patient belonging to ASA 1and 2 Patient belongings to age 18 to 70 years Patient giving informed and written consent.

排除标准

  • Patient with known allergy or hypersensitivity to dexmedetomidine Patient with history of ischemic heart disease, second or third degree heart block, head injury, uncontrolled hypertension, uncontrolled diabetes, pregnancy,and previous craniotomy incision Patient with respiratory disease and predicted difficult airway Patient who refuse to give consent.

结局指标

主要结局

To compare mean arterial pressure

时间窗: Baseline 5 min after, 10 min after after drug administration before laryngosopy and intubation, at 1 min, 3 min, 5 min after intubation,before pin insertion at 1min, 5 min, 10 min,20 min,30 min,60 min afterpin insertion,sedation status at baseline and 10 min after drug administration

次要结局

  • To compare systolic and diastolic blood pressure along with sedation score and adverse effects(Baseline 5 min after, 10 min after after drug administration before laryngosopy and intubation, at 1 min, 3 min, 5 min after intubation,before pin insertion at 1min, 5 min, 10 min,20 min,30 min,60 min afterpin insertion,sedation status at baseline and 10 min after drug administration)

研究者

发起方
King George Mrdical University
申办方类型
Other [nil]

研究点 (1)

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