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Effects of Two Different Sedative Regimens in Traumatic Brain Injury

Cerebral hemodynamic effects of ketamine-propofol versus ketamine- dexmedetomidine sedation in mechanically ventilated patients with severe traumatic brain injury: A prospective randomized , double-blinded study - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087453
Enrollment
42
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: G936- Cerebral edema

Interventions

Intervention1: Ketamine-Dexmedetomidine: Intravenous Ketamine at the dose of 1-5mg/kg/hr and Intravenous dexmedetomidine at the dose of 0.3-0.75 mcg/kg/hr to patients of severe traumatic brain injury

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients between age group 18 years to 65 years with severe TBI b) Severe TBI patients for conservative management c) Radiological evidence of raised ICP - Marshall CT score more than 2

Exclusion criteria

Exclusion criteria: a) Patients with thrombocytopenia (platelet count less than 100000 per mm3) or coagulopathy(INR more than 1.5) b) Polytrauma with Injury severity Score more than 25 c) Patient with unstable hemodynamics d) Infection at the proposed site of ICP catheter insertion e) Patients included in the study who undergo decompressive hemicraniectomy in the course of ICU management.

Design outcomes

Primary

MeasureTime frame
Time spent in Maintaining of Cerebral perfusion pressure above 60mm Hg during the first 48 hours of either sedative regimen.Timepoint: from admission till completion of 48hrs of sedative regimen

Secondary

MeasureTime frame
Duration of Cerebral perfusion pressure below normal values (CPP excursion)Timepoint: Tfrom admission till completion of 48hrs of sedative regimen;Duration of Intracranial pressure above normal values (ICP crisis)Timepoint: from admission till completion of 48hrs of sedative regimen;TCD Mean pulsatility index values more than 1.4 at pre-defined time intervalTimepoint: from admission till completion of 48hrs of sedative regimen;Emergency neurosurgical intervention as rescue measures.Timepoint: from admission till death/discharge;GCS at discharge from ICUTimepoint: upon discharge from ICU;Incidence of mortalityTimepoint: from admission till death/discharge

Countries

India

Contacts

Public ContactDr Kajal Jain

Post Graduate Institute of Medical Education and Research

kajalteji@gmail.com9814528468

Outcome results

None listed

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