Comparison of anesthetic drug i.e., Ketofol versus Sevoflurane on brain relaxation in patients with severe traumatic brain injury

Comparison of ketofol vs sevoflurane on brain relaxation in patients with severe traumatic brain injury a prospective randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095439

Enrollment

100

Registered

2025-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: G973- Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure

Interventions

Intervention1: Comparison of ketofol versus sevoflurane on brain relaxation in patents with severe traumatic brain injury patients undergoing emergency decompressive surgery: Comparison in brain relax

Eligibility

Inclusion criteria

Inclusion criteria: Patients with severe head injury GCS less than 9, scheduled for emergency evacuation of acute traumatic hematoma such as subdural hematoma, brain contusion, subarachnoid haemorrhage, diffuse axonal injury or a combination of these injuries

Exclusion criteria

Exclusion criteria: Patients with extradural hematoma (EDH), TBI patients managed conservatively, associated cervical spine injury, major thoraco-abdominal trauma or patients with history of uncontrolled hypertension, cardiac, renal, hepatic dysfunction, psychiatric disorder, neurodegenerative disorder, pregnancy, history of allergic reaction to study drug and those refusing consent will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Comparison of ketofol vs sevoflurane on brain relaxation score (BRS) at the time of opening of dura during emergency decompressive neurosurgery in severe traumatic brain injury patientTimepoint: Brain relaxation between ketofol and sevoflurane maintenance group of anaesthesia in patents with severe traumatic brain injury undergoing emergency decompressive neurosurgery will be noted at the time of opening the dura using a 4 point brain relaxation score.	—

Measure

Time frame

Comparison of ketofol vs sevoflurane on brain relaxation score (BRS) at the time of opening of dura during emergency decompressive neurosurgery in severe traumatic brain injury patientTimepoint: Brain relaxation between ketofol and sevoflurane maintenance group of anaesthesia in patents with severe traumatic brain injury undergoing emergency decompressive neurosurgery will be noted at the time of opening the dura using a 4 point brain relaxation score.

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Secondary

Measure	Time frame
To compare the effect of ketofol vs sevoflurane on 1. Intra-operative hemodynamics 2. Neurological outcome of the patient (GOSE) at discharge, 30 and 90 days post injury Timepoint: Intra-op hemodynamics will be noted at baseline, induction of anaesthesia, intubation, drilling of burr hole, beginning of craniotomy, removal of bone flap, dural opening, every 10 mins until the 1st hour after dural opening, followed by every hour until the end of surgery outcome will be assessed at discharge, 30 days and 90 days post injury	—

Measure

Time frame

To compare the effect of ketofol vs sevoflurane on 1. Intra-operative hemodynamics 2. Neurological outcome of the patient (GOSE) at discharge, 30 and 90 days post injury Timepoint: Intra-op hemodynamics will be noted at baseline, induction of anaesthesia, intubation, drilling of burr hole, beginning of craniotomy, removal of bone flap, dural opening, every 10 mins until the 1st hour after dural opening, followed by every hour until the end of surgery outcome will be assessed at discharge, 30 days and 90 days post injury

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Countries

India

Contacts

Public ContactSankho Chouudhury

All India Institute Of Medical Sciences, New Delhi

keshavgoyalster@gmail.com9999079795

Outcome results

None listed

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