Comparative evaluation of ONSD in patients undergoing laparoscopic cholecystectomy using low and standard pressures of gas insufflations

PGIMER1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2014年9月12日最近更新: 2014年10月17日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: PGIMER
入组人数: 200
试验地点: 1
主要终点: To compare the effect of low pressure vs standard pressure pneumoperitoneum on ICP using ocular USG to measure ONSD.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

CO2 pneumoperitoneum increases intracranial pressures during laparoscopy. Measurement of optic nerve sheath diameter using optic nerve ultrasound is an accurate and non invasive bedside tool for detection of raised intracranial pressure. Till date no study has compared the effect of low pressure and standard pressure for pneumoperitoneum on intracranial pressures.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•Patients in Group S will undergo laparoscopic cholecystectomy using standard (12-16 mm Hg) pressures whereas patients in Group L will undergo laparoscopy under low pressures (8-10 mm Hg).
•Patients aged 18-80 years and belonging to ASA I-III will be included.

排除标准

•We will exclude patients with orbital trauma as optic sonography in such patients is technically difficult.

结局指标

主要结局

To compare the effect of low pressure vs standard pressure pneumoperitoneum on ICP using ocular USG to measure ONSD.

时间窗: 20 minutes after CO2 pneumoperitoneum with 30 degree reverse Trendelburg position

次要结局

未报告次要终点

研究者

发起方

PGIMER

申办方类型

Research institution and hospital

研究点 (1)

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