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 site in 1 country100 target enrollmentStarted: January 12, 2021Last updated: November 16, 2021

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: AIIMS Jodhpur
Enrollment: 100
Locations: 1
Primary Endpoint: 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

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 .

Study Design

Study Type: Interventional
Allocation: Computer generated randomization
Masking: Participant and Investigator Blinded

Eligibility Criteria

Ages: 18.00 Year(s) to 80.00 Year(s) (—)
Sex: All

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

•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.

Outcomes

Primary Outcomes

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

Time Frame: At Baseline, 24 Hours, 48 Hours after sedation.

Secondary Outcomes

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)

Investigators

Sponsor

AIIMS Jodhpur

Sponsor Class

Research institution and hospital

Study Sites (1)

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