| CTRI Number |
CTRI/2025/05/087453 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Two Different Sedative Regimens in Traumatic Brain Injury |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pritam Panigrahi |
| Designation |
Senior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7678146494 |
| Fax |
|
| Email |
pritampanigrahi6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Jain |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814528468 |
| Fax |
|
| Email |
kajalteji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Jain |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814528468 |
| Fax |
|
| Email |
kajalteji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, level 4, Nehru Hospital, PGIMER Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pritam Panigrahi |
Postgraduate Institute of Medical Education and Research |
Trauma Intensive Care Unit, Level 3, Advanced Trauma Centre, PGIMER Chandigarh
Chandigarh
CHANDIGARH |
7678146494
pritampanigrahi6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(Intramural), PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G936||Cerebral edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 requiring mechanical ventilation. |
| Comparator Agent |
Ketamine-Propofol |
Intravenous Ketamine at the dose of 1-5mg/kg/hr and Intravenous Propofol at the dose of 3-9mg/kg/hr to patients of severe traumatic brain injury requiring mechanical ventilation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time spent in Maintaining of Cerebral perfusion pressure above 60mm Hg during the
first 48 hours of either sedative regimen. |
from admission till completion of 48hrs of sedative regimen |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Cerebral perfusion pressure below normal values (CPP excursion) |
Tfrom admission till completion of 48hrs of sedative regimen |
| Duration of Intracranial pressure above normal values (ICP crisis) |
from admission till completion of 48hrs of sedative regimen |
| TCD Mean pulsatility index values more than 1.4 at pre-defined time interval |
from admission till completion of 48hrs of sedative regimen |
| Emergency neurosurgical intervention as rescue measures. |
from admission till death/discharge |
| GCS at discharge from ICU |
upon discharge from ICU |
| Incidence of mortality |
from admission till death/discharge |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="0"
Months="10"
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
|
|
Brief Summary
|
Aim : To compare the cerebral hemodynamics of Ketamine-Propofol with Ketamine-Dexmedetomidine in mechanically ventilated patients with severe TBI.
This thesis plan investigates sedation protocols in critically ill patients by comparing ketamine-propofol and ketamine-dexmedetomidine combinations. This study will be conducted in the Trauma Intensive Care unit (TICU) of Department of Anaesthesia and Intensive Care. PGIMER Chandigarh from may 2025-november 2025 after approval by Institute Ethics Committee and Clinical Trials Registry of India (CTRI) and written informed consent of patient relatives. The study addresses a lack of evidence regarding the synergistic effects of these drug pairings on hemodynamic stability, depth of sedation, and potential adverse outcomes. A total of 42 patients admitted with severe traumatic brain injury and requiring mechanical ventilation will be assessed for elligibility. Employing a prospective, randomized design, it incorporates continuous monitoring of intracranial pressure (ICP), cerebral perfusion pressure (CPP), and other clinical parameters to evaluate outcomes.
Demographics will be recorded in the form of age, sex, body mass index (BMI), GCS at presentation, Marshall CT score and mode of injury.
Primary outcome is calculating the Time spent in Maintaining of Cerebral perfusion pressure above 60mm Hg during the first 48 hours of either sedative regimen. Nomral CPP range in 60-70mmHg. any change from this range will be labelled as CPP excursion, |