| CTRI Number |
CTRI/2025/09/095439 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of anesthetic drug i.e., Ketofol versus Sevoflurane on brain relaxation in patients with severe traumatic brain injury |
|
Scientific Title of Study
|
Comparison of ketofol vs sevoflurane on brain relaxation in patients with severe traumatic brain injury a prospective randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sankho Chouudhury |
| Designation |
Senior Resident (DM) |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Deptartment of Neuroanaesthesiology and Neurocritical care, Cardiothroacic and Neurosciences centre, AIIMS New Delhi, 110029
New Delhi
DELHI
110049
India |
| Phone |
9903135327 |
| Fax |
|
| Email |
sankhochoudhury12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Keshav Goyal |
| Designation |
Senior Resident (DM) |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Neuroanaesthesiology and Neurocritical care, Cardiothoracic and Neurosciences centre, AIIMS Delhi, 110029
New Delhi
DELHI
110049
India |
| Phone |
9999079795 |
| Fax |
|
| Email |
keshavgoyalster@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sankho Chouudhury |
| Designation |
Senior Resident (DM) |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Deptartment of Neuroanaesthesiology and Neurocritical care, Cardiothroacic and Neurosciences centre, AIIMS New Delhi, 110029
New Delhi
DELHI
110049
India |
| Phone |
9903135327 |
| Fax |
|
| Email |
sankhochoudhury12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptartment of Neuroanaesthesiology and Neurocritical care, Cardiothroacic and Neurosciences centre, AIIMS New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
ALL India Institute Of Medical Sciences |
| Address |
AIIMS, Ansari Nagar, New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sankho Choudhury |
Jai Prakash Narayan Apex Trauma Centre |
Deptartment of Neuroanaesthesiology and Neurocritical care, Cardiothroacic and Neurosciences centre, AIIMS New Delhi, 110029
New Delhi
DELHI |
9903135327
sankhochoudhury12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of ketofol versus sevoflurane on brain relaxation in patents with severe traumatic brain injury patients undergoing emergency decompressive surgery |
Comparison in brain relaxation scores in severe traumatic brain injury patients taken for decompressive surgery at the time of dural opening between ketofol based maintenance anaesthesia using a dose of (1mg ketamine: 5mg propofol) at 0.6-0.9 ml/kg/hour intravenously or (by using sevoflurane based maintenance anaesthesia at a minimum alveolar concentration (MAC) of less than 1 in a mixture of air and oxygen at a fractional inspired concentration of 0.5 till the end of surgery.
To compare hemodynamics between sevoflurane and ketofol anaesthesia at various timepoints such as Baseline, induction of anesthesia, at time of intubation, drilling of burr hole, beginning of craniotomy, removal of bone flap, dural opening and at 10, 20, 30, 40, 50, 60, 120, 360 minutes post dural opening groups.
To look at neurological outcomes of the patient using the extended Glasgow outcome scale at discharge, 30 days and 90 days post injury. |
| Comparator Agent |
Comparison of ketofol versus sevoflurane on brain relaxation, intraoperative hemodynamics and post-operative neurological outcome in severe traumatic brain injury patients undergoing emergency decompressive neurosurgery |
We will be comparing ketofol versus sevoflurane based anaesthesia as maintainence agent intra-operatively during emergency decompressive surgery in severe TBI patients.
We will be inducing anaesthesia in both sevoflurane and ketofol group using fentanyl 2 micrograms/kg i.v. along with propofol 2 mg/kg and rocuronium at 1 mg/kg i.v.
We will then maintain anaesthesia in ketofol group by preparing in a 50 ml syringe containing 40 ml propofol (10 mg/ml) and 8 ml of ketamine (10 mg/ml) with a total volume of 48 ml. The ratio of ketamine to propofol will be (1:5) the drug will be administered using a manual controlled infusion pump and rate of infusion will be titrated to a dose of 0.6-0.9 ml/kg/hour and depth of anaesthesia will be monitored using bispectral index to maintain value between 40 to 60.
In the maintenance group of sevoflurane the MAC will be maintained to less than 1 and depth of anaesthesia will be monitored using BIS of 40-60.
The primary outcome of brain relaxation score will be assessed by the neurosurgeon (blinded) using 4 point brain relaxation score at opening of the dura.
Assessment of hemodynamics between the two groups will be done at the following timepoints i.e., baseline, induction of anaesthesia, intubation, drilling of burr hole, beginning of craniotomy, removal of bone flap, opening of dura and at 10, 20, 30, 40 , 50, 60, 120, 360 minutes post dural opening or end of surgery whichever is earlier.
The assessment of neurological outcome of the patients will be assessed using the extended Glasgow coma scale at discharge and thereafter at 30 and 90 days post injury.
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 patient |
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Our study proposes a prospective, RCT to compare the effect of ketofol versus sevoflurane based anaesthesia on brainn relaxation during emergency decompressive surgery in severe traumatic brain injury patients. The study will also assess intra-operative hemodynamics to determine which anaesthetic agent is better for severe TBI patients. Additionally, the trial will evaluate the neurological outcome of the patients at discharge and at 30 and 90-days post-injury, aiming to identify any difference in functional recovery. This research will provide valuable insights into the optimal anaesthetic choice for improving both immediate surgical outcomes and long term recovery in severe TBI patients. |