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临床试验/CTRI/2025/07/091708
CTRI/2025/07/091708尚未招募4 期

Comparison of non-invasive intracranial assessment during laproscopic cholecystectomy using the Budohoski equation versus Xing Wang equation

Indira Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年8月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Comparison of mean estimated ICP between the two groups at each time point

研究概览

简要总结

Primary objective To compare intracranial pressure derived from Budohoski equation to that derived from Xing & Wang equation in patients undergoing laproscopic cholecystectomy

Secondary Objectives:(i)                 To observe and compare the effect of different intra-peritoneal insufflation pressures on cerebral blood flow velocity and ICP

(ii)               To observe and compare the effect of different intra-peritoneal insufflation pressures on ONSD and ICP

(iii)             To observe and compare the effect of ICP elevation during pneumoperitoneum with post-operative emergence from anesthesia

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • ASA physical status I and II Body mass index less than 30.

排除标准

  • Known intracranial pathology or raised ICP Ophthalmic disease affecting optic nerve Carotid artery stenosis or vascular malformations Poor acoustic windows for TCCD Pregnancy.

结局指标

主要结局

Comparison of mean estimated ICP between the two groups at each time point

时间窗: Timepoint 1- After securing the airway, but prior to pneumoperitoneum | Timepoint 2- At 15 minutes after insufflation | Timepoint 3- 2 minutes after release of pneumoperitoneum

次要结局

  • Correlation between TCCD-derived ICP and ONSD at each time point
  • Time of emergence from anesthesia(After discontinuation of volatile agent uptil eye opening to verbal command)
  • Incidence of delayed emergence between the two groups(Will start from 15 minutes after stopping the anesthetics and administering the reversal agent from muscle relaxation)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sunil Sharma

Indira Gandhi Medical College

研究点 (1)

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