跳至主要内容
临床试验/CTRI/2025/04/085717
CTRI/2025/04/085717尚未招募不适用

Comparison of cerebro vascular reactivity to carbon dioxide at equi MAC doses of Isoflurane and sevoflurane in neonates (Varis study): A randomised controlled study

Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Change in mean flow velocity of the distal MCA (M1 segment) with the change in EtCO2 from 35mmHg to 45mmHg

研究概览

简要总结

Inhaled anaesthetics increase the Cerebral Blood Flow and affects cerebrovascular reactivity  to CO2,  largely maintained till 1 minimum alveolar concentration (MAC).  The cerebral vasodilatory effects of inhaled anaesthetic agents are far more pronounced in children as compared to adult population. Sevoflurane and Isoflurane do not have similar effects on cerebral circulation. Sevoflurane is a less potent cerebral vasodilator and preserves the dynamic Cerebral Autoregulation as compared to isoflurane when administered in equal MAC doses. Study in adults have suggested that Isoflurane preserves the cerebro vascular reactivity to carbon dioxide upto 1 MAC, whereas sevoflurane has been shown not to have effect within a range of 0.5-1 MAC.However, there is no data on effect of anaesthetic agents on cerebro vascular reactivity to carbon dioxide in neonates. We hypothesized that sevoflurane would preserve the cerebro vascular reactivity to carbon dioxide  better than isoflurane in neonates undergoing non cardiac surgery under GA at equal MAC doses when the End Tidal carbon dioxide (EtCO2) changes from 35 mmHg to 45 mmHg.

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
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Term neonates Scheduled for non Intrathoracic and non neurosurgical procedures under anaesthesia.

排除标准

  • Hemodynamically unstable and on inotropes Congenital heart disease Heart failure or respiratory disorders Preterm neonates.

结局指标

主要结局

Change in mean flow velocity of the distal MCA (M1 segment) with the change in EtCO2 from 35mmHg to 45mmHg

时间窗: 15 minutes and 30 minutes

次要结局

  • 1.Change in systolic flow velocity of the distal MCA (M1 segment) with change in EtCO2 from 35 mmHg to 45 mmHg(2.Change in diastolic flow velocity of the distal MCA (M1 segment) with change in EtCO2 from 35 mmHg to 45 mmHg)

研究者

发起方
Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验