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临床试验/CTRI/2026/01/102564
CTRI/2026/01/102564尚未招募不适用

Comparison of Target controlled infusion (TCI) of dexmedetomidine versus TCI propofol for one lung ventilation: A randomised clinical study

Dr Shagun Bhatia Shah1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月19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
60
试验地点
1

研究概览

简要总结

This prospective, interventional, parallel-arm, single-centred, randomised controlled study aims to compare the effectiveness of a target-controlled infusion of dexmedetomidine with a target-controlled infusion of propofol for the prevention of hypoxemia during one-lung ventilation at doses that maintain surgical depth of anaesthesia (bispectral index 40-60). The study shall include 60 adult patients aged 18-70 years, weighing 45-80kg, undergoing lung resection surgery under one lung ventilation. Patients who refuse to give consent, have egg allergy, bradyarrhythmias, respiratory or hepatorenal dysfunction, or are posted for bilateral resection of lung lesions, or pneumonectomy shall be excluded from the study. The study, spanning six months, shall be conducted at Rajiv Gandhi Cancer Institute and Research Centre. The patients shall be randomly allocated to two groups dexmedetomidine group (Group D; n = 30) and propofol group (Group P; n = 30). Our primary outcome measure would be the difference in arterial partial pressure of oxygen (PaO2) recorded at baseline, and PaO2 recorded 60 min after initiation of one-lung ventilation. Our secondary outcomes would be the PaO2, PaCO2, heart rate, mean arterial pressure, perfusion index, and dynamic compliance measured at specific time points (baseline, two lung ventilation just before one lung ventilation, 30 min, 60 min and 90 min after initiation of one lung ventilation, end surgery). Intraoperative cardiac and pulmonary complications, postoperative pulmonary complications and Clavien-Dindo major complications shall also be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Weighing 45-80kg, Undergoing lung resection surgery under one lung ventilation.

排除标准

  • Patient refusal to give consent, Egg allergy, Bradyarrhythmias, Respiratory dysfunction, Hepatorenal dysfunction, Posted for bilateral resection of pulmonary lesions or pneumonectomy.

研究者

发起方
Dr Shagun Bhatia Shah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shagun Bhatia Shah

Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi

研究点 (1)

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