Comparison of dose of Propofol when used in combination with ketamine versus Fentanyl for sedation and anti inflammatory effects in mechanically ventilated patients A double blind randomised controlled study

AIIMS Jodhpur1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年1月12日最近更新: 2021年11月16日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: AIIMS Jodhpur
入组人数: 100
试验地点: 1
主要终点: To compare the dose of Propofol required to achieve a target sedation score ( RASS of 0 to -2) when used in combination with Ketamine versus Fentanyl

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

Comparison of the dose of Propofol when used in combination with Ketamine versus Fentanyl for sedation and anti inflammatory effects in mechanically ventilated adult patients A double blind randomised controlled study.

Purpose of trial: To find out optimal sedatives and dose in ICU and to know whether Ketamine better than Fentanyl .

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and 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

•All ICU patients between 18 to 80 years who are expected to be on mechanical ventilation for more than 48 hours.

排除标准

•Patients weaned of mechanical ventilation within 48 hrs of mechanical ventilation 2) Patients who are on non invasive mode of ventilation 3) Patients who had cardiac arrest and received CPR within 48 hrs of mechanical ventilation 4) Patients having history of dementia, Psychiatric disorder, on antipsychotic or antidepressants prior to ICU admission 5) Pregnant females and patients having known hypersensitivity to any of the sedative agents 6) Cardiogenic shock, Acute decompensated heart failure, MI 7) Patients having end stage liver failure ( Child Pugh C) 8) Primary neurological injury (TBI, Stroke, SCI, Anoxic brain injury, Brain edema) 9) Hemodynamically unstable patients.

结局指标

主要结局

To compare the dose of Propofol required to achieve a target sedation score ( RASS of 0 to -2) when used in combination with Ketamine versus Fentanyl

时间窗: At Baseline, 24 Hours, 48 Hours after sedation.

次要结局

1) To compare the residual effect on sedation fue to Ketamine versus Fentanyl on stopping the infusion after 72 hours(2) To compare the anti inflammatory effects of Propofol and Ketamine versus Propofol and Fentanyl by measuring serum TNF alfa and IL 6 levels)

研究者

发起方

AIIMS Jodhpur

申办方类型

Research institution and hospital

研究点 (1)

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