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临床试验/CTRI/2025/07/089978
CTRI/2025/07/089978尚未招募不适用

A randomized controlled study of lung protective ventilation and conventional ventilation in patients undergoing abdominal laparoscopic surgeries under general anesthesia at SMS Medical College, Jaipur

SMS Medical College and Hospitals1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2025年7月12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
188
试验地点
1
主要终点
To assess and compare intraoperative Pulmonary Oxygenation in both groups by calculating ratio of Partial pressure of oxygenation in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2), PaO2 (mmHg), PaCO2 (mmHg), PH values intraoperatively by Arteiral Blood Gas analysis

研究概览

简要总结

This prospective, randomized comparative study is being conducted at SMS Medical College and Hospital, Jaipur, to evaluate the effects of lung protective ventilation (LPV) versus conventional ventilation (CV) strategies on pulmonary function in patients undergoing elective abdominal laparoscopic surgery under general anesthesia. A total of 188 patients will be enrolled and randomized into two equal groups (LPV and CV). Parameters such as arterial blood gas values, ventilatory mechanics, and intraoperative hemodynamic changes will be recorded at predefined time intervals. The aim is to assess whether LPV improves intraoperative pulmonary outcomes without adverse hemodynamic effects, thereby supporting safer anesthetic practices in laparoscopic procedures.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give written informed consent.
  • 2.Patients 18-60 years planned for laparoscopic surgeries.
  • 3.American Society of Anaesthesiologists (ASA) grade I and II.

排除标准

  • Patient should not be part of any other study.
  • Pateints with the need to continue prolonged mechanical ventilation after surgery.
  • Patients with abnormal spirometry.

结局指标

主要结局

To assess and compare intraoperative Pulmonary Oxygenation in both groups by calculating ratio of Partial pressure of oxygenation in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2), PaO2 (mmHg), PaCO2 (mmHg), PH values intraoperatively by Arteiral Blood Gas analysis

时间窗: After induction , 30 min after pneumoperitoneum and then at the end of surgery

次要结局

  • To assess and compare change in Hemodynamics parameters in both groups.(After induction, 15min,)
  • To assess and compare lung mechanics in both groups(After induction, 15min,)

研究者

发起方
SMS Medical College and Hospitals
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Indu Verma

Sawai Man Singh Medical College and Hospitals

研究点 (1)

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