Comparison of combination of sedatives(Propofol and ketamine vs Propofol and Fentanyl) in patients on ventilator

Not yet recruiting

• Conditions: Acute pulmonary insufficiency following nonthoracic surgery, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (3) ICD-10 Condition: I999||Unspecified disorder of circulatory system,

• Registration Number: CTRI/2021/11/038112
• Lead Sponsor: AIIMS Jodhpur

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

1. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	At Baseline, 24 Hours, 48 Hours after sedation.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AICU, AIIMS Jodhpur,; 🇮🇳 Jodhpur, RAJASTHAN, India

AICU, AIIMS Jodhpur,

🇮🇳Jodhpur, RAJASTHAN, India

Dr Venkatachalam K

Principal investigator

9944561826

VENKATACHALAMNEIGRIHMS@GMAIL.COM