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临床试验/CTRI/2023/06/053603
CTRI/2023/06/053603已完成不适用

Influence of dexmeditomidine in scalp block with ropivacaine 0.25% for attenuation of nociceptive and haemodynamic responses to skull pin placement in neurosurgical patients undergoing craniotomy:A prospective randomized comparative study.

mahatma gandhi hospital and medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To analyse and compare the change in HR,using lead II of ECG,systolic bp,diastolic BP at different time points after skull pin placement from baseline in both the groups using invasive blood pressure monitoring.

研究概览

简要总结

The use of skull pin head holder to stabilise the head during craniotomy produces a strong noxious stimulus and sympathetic activation, resulting in abrupt increase in heart rate and arterial blood pressure and may increase the cerebral blood flow and intracranial pressure.Different anaesthetic and pharmacological techniques have been used to attenuate haemodynamic response to skull pin placement.Of the various methods mentioned, scalp block with local anaesthetic (LA) drug is commonly used. To prolong or for added effect, we add adjuvants to LAs. Alpha 2 agonists are one among the various adjuvants used along with  LAs in scalp block.

 

The Mayfield skull-pin head holder is used to stabilize the head during neurosurgical procedures.They support the head without any direct pressure on the face, allow access to the airway and hold the head firmly in one position that can be finely adjusted for optimal neurosurgical exposure.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

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

入选标准

  • Age:18-65 ASA 1 & 2 Scheduled for elective neurosurgical procedures.
  • Agreed for written & informed consent.

排除标准

  • Uncontrolled hypertensive patients.
  • Pre operative bradycardia.
  • Ischemic heart disease.
  • Cardiac arrhythmia.
  • Hepatic and renal disease.
  • Allergy to study drugs.
  • Past history of craniotomy.
  • Pregnant and lactating women.

结局指标

主要结局

To analyse and compare the change in HR,using lead II of ECG,systolic bp,diastolic BP at different time points after skull pin placement from baseline in both the groups using invasive blood pressure monitoring.

时间窗: 15 minutes from baseline to 1 hour, | then half an hour till 4 hours

次要结局

  • The secondary outcome of the study will be on intraoperatively hemodynamic monitoring including blood pressure, MAP,HR and SPO2.(5 Min observation till 15 mins,then 15 mins observation till 1 hour,then half n hour observation for 4 hours.)

研究者

发起方
mahatma gandhi hospital and medical college
申办方类型
Private medical college

研究点 (1)

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