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临床试验/CTRI/2024/02/062471
CTRI/2024/02/062471尚未招募2 期

The Comparison of Bispectral Index Value Under Spinal Anaesthesia in Elderly Patients with Bupivacaine versus Bupivacaine and Fentanyl

Vinayaka Missions Research Foundation1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2024年2月12日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
111
试验地点
1
主要终点
Bispectral index values

研究概览

简要总结

Bispectral index is a continuous form of non invasive complex processed electroencephalogram derived parameter which has been validated as a quantifiable objective measure  of sedative hypnotic effects of drugs by taking elder population as sample to measure the depth of the anaesthesia to the drug given intrathecally  such as injection bupivacaine 0.5% 2.5ml as separate group along with that injection fentanyl 0.2 ml as separate group where these elderly population itself a physiologically  compromised condition need greater modification in dosage ,this study helps in identification of higher segmental block  and its impact in hemodynamic effects in elderly population

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Both Male and Female Patients 2.above 65 years to 99 year old 3.undergoing elective surgeries under spinal anaesthesia 4.under ASA 1 2 and 3.

排除标准

  • 1.under ASA 4 and 5 2.uncontrolled systemic disorder 3.neurological impairment
  • demyelinating disease 5.patient refusal.

结局指标

主要结局

Bispectral index values

时间窗: Bispectral index values every 5 minutes for first hour

次要结局

  • Level of spinal anaesthesia(for first hour)
  • Haemodynamic stability(1st hour)

研究者

发起方
Vinayaka Missions Research Foundation
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Prasanna vadhanan

vinayaka Mission Research Foundation

研究点 (1)

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