Comparing the effectiveness of two different medication regimen for sedating patients with severe injury to the brain due to trauma who have been admitted in ICU

A prospective randomized blinded controlled trial on the efficacy of Propofol-Fentanyl versus Ketamine-Dexmedetomidine sedation in patients with severe traumatic brain injury admitted in trauma intensive care - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068952

Enrollment

Registered

2024-06-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Group Ketamine/ Dexmedetomidine (KD): Agent: Intravenous infusion of Ketamine at 1-5mg/kg/hr and Dexmedetomidine at 0.3-0.75 mcg/kg/hr for 48 hours Control Intervention1: Group Propofol

Eligibility

Inclusion criteria

Inclusion criteria: Severe TBI with GCS less than or equal to 8 Undergoing conservative management ASA I to III

Exclusion criteria

Exclusion criteria: Surgical management for TBI Mild or Moderate Head Injury with GCS more than or equal to 9 Polytrauma Contraindication to use of the drugs included in the trial Lack of patient consent

Design outcomes

Primary

Measure	Time frame
Time spent in goal RASS, i.e., RASS score of -3 to -4Timepoint: every 15 minutes till goal RASS is achieved and every hour thereafter till 48 hours	—

Secondary

Measure	Time frame
Decrease in serum cortisol level at 48 hours as a measure of stressTimepoint: On admission and at 48 hours;FOUR score at ICU dischargeTimepoint: At admission and Discharge;Incidence of hemodynamic alterations (hypertension, hypotension and bradycardia)Timepoint: Same time as RASS.;Incidence of side effects of drugs used in the study like Propofol Infusion Syndrome (PRIS), constipation and acute withdrawal.Timepoint: Same Time as RASS;Incidence of Ventilator Associated Pneumonia (VAP)Timepoint: Same time as RASS;Outcome at 3 months using GOSETimepoint: At 3 months;Time to achieve Goal RASSTimepoint: every 15 minutes till goal RASS is achieved	—

Measure

Time frame

Decrease in serum cortisol level at 48 hours as a measure of stressTimepoint: On admission and at 48 hours;FOUR score at ICU dischargeTimepoint: At admission and Discharge;Incidence of hemodynamic alterations (hypertension, hypotension and bradycardia)Timepoint: Same time as RASS.;Incidence of side effects of drugs used in the study like Propofol Infusion Syndrome (PRIS), constipation and acute withdrawal.Timepoint: Same Time as RASS;Incidence of Ventilator Associated Pneumonia (VAP)Timepoint: Same time as RASS;Outcome at 3 months using GOSETimepoint: At 3 months;Time to achieve Goal RASSTimepoint: every 15 minutes till goal RASS is achieved

—

Countries

India

Contacts

Public ContactDr Yojana Karki

Postgraduate Institute of Medical Education and Research (PGIMER)

drsumanarora@hotmail.com9316025807

Outcome results

None listed

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