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Effect of drugs Ketofol versus Fentanyl and Midazolam for sedation on Brain injury markers in traumatic Brain Injury Patients in ICU

Effect of Ketofol versus Fentanyl and Midazolam infusion for ICU Sedation on Brain Injury Biomarkers in Isolated Severe Traumatic Brain Injury Patients – A Prospective Randomized Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064037
Enrollment
50
Registered
2024-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: - Health Condition 2: S069- Unspecified intracranial injury

Interventions

Intervention1: Ketofol for ICU sedation: IV infusion of ketofol (1:4)will be given
Propofol at the rate of 0.5 mg/kg bolus followed by maintenance at 25-50 mcg/kg/min (1.5-3mg/kg/hr) and Ketamine at the rate of 0.125mg/kg bolus followed by maintenance at 0.375-0.75 mg/kg/hr. Sedatio

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Severe traumatic brain injury patients admitted into Neuro Trauma ICU within 48 hours after the trauma. 1)Patients with a primary diagnosis of isolated severe TBI GCS 3-8 2) Patients between 18-65 years of age and of either sex

Exclusion criteria

Exclusion criteria: 1) Patients with persistent GCS of 3 with bilateral fixed dilated pupils after initial resuscitation. 2) Also includes those patients who underwent decompressive craniectomy before ICU admission 3) In the absence of a guardian to give consent for the study 4) Life-threatening polytrauma 4) Patients in shock requiring vasopressor support at ICU admission 5) Pre-existing brain disease 6) Pregnancy 7) Patients allergic to drugs being used for sedation 8) Patients with deranged hepatic and renal parameters

Design outcomes

Primary

MeasureTime frame
To compare the levels GFAP and UCH L1 levels after 48 hrs of ICU admission using ketofol versus fentanyl and midazolam as sedationTimepoint: To compare the levels GFAP and UCH L1 levels after 48 hrs of ICU admission using ketofol versus fentanyl and midazolam as sedation

Secondary

MeasureTime frame
To compare the levels GFAP and UCH L1 levels after 5 days of ICU admission 2) Duration of ICU and Hospital stay Timepoint: after 5 days of ICU admission

Countries

India

Contacts

Public ContactDr Suman Sokhal

AIIMS

sumansokhal82@gmail.com01126594420

Outcome results

None listed

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