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临床试验/CTRI/2024/02/062705
CTRI/2024/02/062705招募中不适用

Comparison of postoperative pulmonary functions and outcomes in patients undergoing major open abdominal surgeries between general anaesthesia with thoracic epidural and thoracic continuous spinal anaesthesia: an exploratory randomized study

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
To compare the peak expiratory flow rate assessed using hand held spirometer at predefined time points

研究概览

简要总结

This is an exploratory randomized, single blinded, parallel group study to compare post operative pulmonary functions and outcomes in patients receiving General anaesthesia with Thoracic epidural versus Thoracic continuous spinal anaesthesia for major open abdominal surgeries that will be conducted in India. The hypothesis is that the pre operative pulmonary functions would be better preserved in regional anaesthesia (thoracic continuous spinal anaesthesia) as compared to general anaesthesia in patients undergoing major abdominal surgeries. Hence, better postoperative pulmonary functions and outcomes in regional anaesthesia. The primary objective would be to compare peak expiratory flow rate at predefined time intervals [preoperative (T0), immediate postoperative (T1), post operative day 1 (T2), post operative day 2 (T3), post operative day 3 (T4)]. The secondary objectives would be to compare breath holding time and SpO2, incidence of postoperative lung atelectasis (ultrasound assessed),  incidence of other postoperative pulmonary complications (pleural effusion, pneumonia, pneumothorax, acute respiratory distress syndrome), change in trans-diaphragmatic excursion (ultrasound assessed Delta TDI) at predefined time points [preoperative (T0), immediate postoperative (T1), post operative day 1 (T2), post operative day 2 (T3), post operative day 3 (T4)] and all cause in-hospital mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18years Both genders ASA physical status I-III Patient undergoing Elective major abdominal surgery.

排除标准

  • Refusal by the patient Any contraindication to Thoracic Epidural Anaesthesia and Thoracic Continuous Spinal Anaesthesia Emergency surgery Abdominal trauma patient Expected severe hemodynamic instability (pheochromocytoma) Pregnant females BMI more than 35 Severe systemic disease (ASA physical status IV).

结局指标

主要结局

To compare the peak expiratory flow rate assessed using hand held spirometer at predefined time points

时间窗: preoperative (T0) | immediate postoperative (T1) post operative day 1 (T2) | post operative day 2 (T3) | post operative day 3 (T4)

次要结局

  • To compare breath holding time and SpO2 at predefined time points(preoperative (T0))
  • To compare the incidence of postoperative lung atelectasis (ultrasound assessed) at predefined time points(preoperative (T0))
  • To compare the incidence of other postoperative pulmonary complications (pleural effusion, pneumonia, pneumothorax, acute respiratory distress syndrome)(preoperative (T0))
  • To compare postoperative change in trans-diaphragmatic excursion (ultrasound assessed Delta TDI) at predefined time points(preoperative (T0))
  • To compare all cause in-hospital mortality in patients receiving general anaesthesia plus thoracic epidural versus thoracic continuous spinal anaesthesia(throughout the hospital stay of the patient)

研究者

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

Dr Gourav Kumar

AIIMS Rishikesh

研究点 (1)

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