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临床试验/CTRI/2019/08/020826
CTRI/2019/08/020826尚未招募1 期

To compare efficacy of addition of dexmedetomidine or placebo to ropivacaine scalp block to attenuate the hemodynamic response to skull pin placement in neurosurgical procedures

Department Of Anesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月11日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Heart rate , systolic blood pressure , diastolic blood pressure and mean arterial pressure are measured at different time points following skull pin placement .

研究概览

简要总结

This will be a prospective randomised double blind placebo control study  In this study 60 patients belonging to ASA physical status grading 1 and 2 will be allocated into two groups each group containing 30 patients     In group D patients will be recieving 25ml of 0.5 percent ropivacaine with dexmedetomidine 1 microgram per kg and this solution will be  made 30ml       In group R patients will be recieving 25 ml of 0.5 percent ropivacaine with normal saline and solution will be made 30 ml    Heart rate systolic blood pressure diastolic blood pressure and mean arterial pressure are mnoted before skull pin fixation 1 3 5 and 10 min after skull pin fixation Results will be coded after study

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex Patients aged 18 to 65 years American Society of Anesthesiologists physical status grade I and II Patients scheduled for elective neurosurgical procedures under general anesthesia with tracheal intubation.

排除标准

  • Patients with uncontrolled hypertension Patients with preoperative bradycardia, ischemic heart disease, cardiac arrhythmias Patients with severe hepatic and renal disease Patients with past history of craniotomy Patients allergic to study drugs Patients on alpha blockers treatment preoperatively Patient refusal Patient unable to give consent Pregnant women and lactating mothers.

结局指标

主要结局

Heart rate , systolic blood pressure , diastolic blood pressure and mean arterial pressure are measured at different time points following skull pin placement .

时间窗: Heart rate , systolic blood pressure , diastolic blood pressure and mean arterial pressure are measured at 1 3 5 10 minutes following skull pin placement

次要结局

  • 2.Number of episodes of hypertension, hypotension, bradycardia and tachycardia(during study period.)

研究者

发起方
Department Of Anesthesiology and Critical Care
申办方类型
Research institution and hospital

研究点 (1)

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