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临床试验/CTRI/2025/09/095279
CTRI/2025/09/095279招募中不适用

Effect of Ventilation mode on Optic Nerve Sheath Diameter in patients undergoing laparoscopic surgery: A randomised study

University College of Medical Sciences1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
ONSD

研究概览

简要总结

Participants will be randomly allocated to either group V or group P. Monitors will be attached and general anaesthesia will be induced. Mode of ventilation will be kept as per the group allocated. Ventilation will be adjusted to maintain ETCO2 within 35-40 mmHg. ONSD, respiratory parameters, hemodynamics and blood gas parameters will be assessed before induction, 1 and 5 min after intubation, 10, 30 and 60 min after pneumoperitoneum, just before deflation and 5 min after extubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

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 I and II BMI less than 30 kg per metre square.

排除标准

  • history of eye surgery or known case of eye disease like cataract, glaucoma, uncontrolled cardiovascular, respiratory, renal, liver disease brain tumors, epilepsy or other causes which raise ICP, history of head injury or brain surgery.

结局指标

主要结局

ONSD

时间窗: Before Induction | 1 min after intubation | 5 min after intubation | 10 min after pneumoperitoneum | 30 min after pneumoperitoneum | 60 min after pneumoperitoneum | Just before deflation | 5 min after extubation

次要结局

  • Respiratory parameters: Tidal volume, respiratory rate, minute ventilation (MV), EtCO2, Peak pressure (Ppeak), mean airway pressure (Pmean), SpO2(3. Blood gas parameters: PaO2, PaCO2, pH, PaO2/FiO2 ratio)

研究者

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

Poonam

University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi

研究点 (1)

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