Effect of drugs Ketofol versus Fentanyl and Midazolam for sedation on Brain injury markers in traumatic Brain Injury Patients in IC
Phase 4
- Conditions
- Health Condition 1: - Health Condition 2: S069- Unspecified intracranial injury
- Registration Number
- CTRI/2024/03/064037
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To compare the levels GFAP and UCH L1 levels after 5 days of ICU admission <br/ ><br>2) Duration of ICU and Hospital stay <br/ ><br> <br/ ><br>Timepoint: after 5 days of ICU admission