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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038112
Enrollment
100
Registered
2021-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J952- Acute pulmonary insufficiency following nonthoracic surgery Health Condition 2: B968- Other specified bacterial agents as the cause of diseases classified elsewhere Health Condition 3: I999- Unspecified disorder of circulatory system

Interventions

Intervention1: Ketamine: 0.12 mg per kg per hour for 24 hours and 0.06 mg per kg per hour for next 24 hours Control Intervention1: Fentanyl: 1 mcg per kg per hour

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 FentanylTimepoint: At Baseline, 24 Hours, 48 Hours after sedation.—

Secondary

MeasureTime frame
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 3) To compare the dose of injection Noradrenaline required to achieve MAP more than or equal to 65 mmhg with each combination of sedative agentsTimepoint: 48 hours—

Countries

India

Contacts

Public ContactDr Venkatachalam K

AIIMS Jodhpur

drnikhilkothari@gmail.com8003996948

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026