| CTRI Number |
CTRI/2024/06/068952 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effectiveness of two different medication regimen for sedating patients with severe injury to the brain due to trauma who have been admitted in ICU |
|
Scientific Title of Study
|
A prospective randomized blinded controlled trial on the efficacy of Propofol-Fentanyl versus Ketamine-Dexmedetomidine sedation in patients with severe traumatic brain injury admitted in trauma intensive care |
| 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 Yojana Karki |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Anesthesia and Intensive Care, Fourth Floor, Nehru Hospital, PGIMER, Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8968690205 |
| Fax |
|
| Email |
karkiyojana1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Arora |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Anesthesia and Intensive Care, Fourth floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316025807 |
| Fax |
|
| Email |
drsumanarora@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yojana Karki |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Anesthesia and Intensive Care, Fourth floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8968690205 |
| Fax |
|
| Email |
karkiyojana1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Intensive Care, Fourth floor, Office of Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia and Intensive Care |
| Address |
Fourth floor, Office of Department of Anesthesia and Intensive Care, PGIMER, Chandigarh |
| 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 Yojana Karki |
PGIMER, Chandigarh |
Advanced Trauma Centre (ATC) ICU , Level 3, Advanced Trauma Centre
Chandigarh
CHANDIGARH |
8968690205
karkiyojana1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Ketamine/ Dexmedetomidine (KD) |
Agent: Intravenous infusion of Ketamine at 1-5mg/kg/hr and Dexmedetomidine at 0.3-0.75 mcg/kg/hr for 48 hours |
| Comparator Agent |
Group Propofol/Fentanyl (PO) |
Agent: Intravenous infusion of propofol at 3-9mg/kg/hr and Fentanyl at 2-5mcg/kg/hr for 48 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Severe TBI with GCS less than or equal to 8
Undergoing conservative management
ASA I to III |
|
| ExclusionCriteria |
| Details |
Surgical management for TBI
Mild or Moderate Head Injury with GCS more than or equal to 9
Polytrauma
Contraindication to use of the drugs included in the trial
Lack of patient consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time spent in goal RASS, i.e., RASS score of -3 to -4 |
every 15 minutes till goal RASS is achieved and every hour thereafter till 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to achieve Goal RASS |
every 15 minutes till goal RASS is achieved |
| Incidence of hemodynamic alterations (hypertension, hypotension and bradycardia) |
Same time as RASS. |
| Incidence of side effects of drugs used in the study like Propofol Infusion Syndrome (PRIS), constipation and acute withdrawal. |
Same Time as RASS |
| Decrease in serum cortisol level at 48 hours as a measure of stress |
On admission and at 48 hours |
| FOUR score at ICU discharge |
At admission and Discharge |
| Incidence of Ventilator Associated Pneumonia (VAP) |
Same time as RASS |
| Outcome at 3 months using GOSE |
At 3 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Traumatic brain injury (TBI) is a significant global health concern, causing mortality and hospitalizations. It involves both primary and secondary insults to the brain, with secondary injuries being preventable and critical to address. Sedation is crucial in managing TBI, aiming not only for symptom relief but also to optimize patient comfort and neurological outcomes. Propofol and opioids are commonly used for sedation, but they come with risks such as respiratory depression and opioid dependence. Dexmedetomidine and ketamine offer alternatives with fewer unwanted effects. This study aims to compare a traditional sedation regimen with propofol and fentanyl to an opioid-free regimen using ketamine and dexmedetomidine in severe TBI cases to reduce opioid-related risks while ensuring effective sedation and pain management. |