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临床试验/CTRI/2025/09/094599
CTRI/2025/09/094599尚未招募不适用

Effect of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using transorbital ultrasonographic measurement of optic nerve sheath diameter in patients undergoing laparoscopic surgery An observational study

Department of anaesthesiology1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年9月21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
38
试验地点
1
主要终点
To assess the change in intracranial pressure in patients undergoing laparoscopic surgery with combined pneumoperitoneum and Trendelenburg position under general anaesthesia, measured by transorbital ultrasonographic optic nerve sheath diameter (ONSD).

研究概览

简要总结

This observational study aims to assess the effect of pneumoperitoneum and Trendelenburg position on intracranial pressure in patients undergoing laparoscopic surgery under general anaesthesia. Intracranial pressure will be estimated using transorbital ultrasonographic measurement of optic nerve sheath diameter (ONSD) at predefined time points. The hypothesis is that combined pneumoperitoneum and Trendelenburg position increases ONSD, reflecting a rise in intracranial pressure. Secondary objectives include evaluating the correlation of ONSD with end-tidal carbon dioxide and haemodynamic parameters.

研究设计

研究类型
Observational

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 between twenty one and sixty years Both male and female patients American Society of Anesthesiologists (ASA) physical status one to three Body mass index less than thirty kilograms per square metre Scheduled for elective laparoscopic surgery with pneumoperitoneum and Trendelenburg position under general anaesthesia Glasgow coma score of fifteen.

排除标准

  • History of ophthalmic problems that prevent proper use of ultrasound probe Presence of optic nerve disorders such as optic neuritis or optic nerve neoplasm Previous ocular surgery Hyperthyroidism.

结局指标

主要结局

To assess the change in intracranial pressure in patients undergoing laparoscopic surgery with combined pneumoperitoneum and Trendelenburg position under general anaesthesia, measured by transorbital ultrasonographic optic nerve sheath diameter (ONSD).

时间窗: Baseline (before pneumoperitoneum), after creation of pneumoperitoneum in Trendelenburg position, and after desufflation before extubation.

次要结局

  • Change in mean arterial pressure (MAP) and heart rate in relation to ONSD changes.(Baseline (before pneumoperitoneum), after creation of pneumoperitoneum in Trendelenburg position, and after desufflation before extubation.)

研究者

发起方
Department of anaesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Jinan R S

Government Medical College, Kozhikode

研究点 (1)

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