| CTRI Number |
CTRI/2025/11/097868 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study on Efficacy of Dexmedetomidine, Fentanyl and Midazolam on Post Intubation Sedation in Trauma Patients |
|
Scientific Title of Study
|
A Comparative Study on Efficacy of Dexmedetomidine, Fentanyl and Midazolam on Post Intubation Sedation in Trauma Patients |
| 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. M. Senthil Kumar |
| Designation |
Professor and Hod - Department of Emergency Medicine |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room Number 100 Department Of Emergency Medicine
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9443243838 |
| Fax |
|
| Email |
edvmkv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Senthil Marappan |
| Designation |
Professor - Department of Anaesthesiology |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
edvmkv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Jithin Gopan. S |
| Designation |
Post Graduate- Department of Emergency Medicine |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room Number 100 Department Of Emergency Medicine
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
8156996756 |
| Fax |
|
| Email |
gopanjithin@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
Tamilnadu
636308 |
| Type of Sponsor |
Private 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 |
| DrJithin Gopan S |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Room number 100 Department Of Emergency Medicine
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Chinnaseeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU |
8156996756
gopanjithin@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Vinayaka Missions Kirupananda Variyar Medical College and Hospitals ,Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All trauma patients presenting to the Department of Emergency Medicine VMKV MCH during the study period who are intubated in the Emergency Department with age 18-70yrs with American Society of Anaesthesiologists grade I and II |
|
| ExclusionCriteria |
| Details |
Exclusion criteria included significant hepatic and renal impairment, hypotension, bradycardia, and a known allergy to any of the study drug. Patient, for whom consent was not given, lost in follow up during the study period, who died during the study period, and American Society of Anaesthesiologists (ASA) grade more than III are also excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequacy of sedation measured by RASS score at predefined intervals |
Baseline, 30 min, 4 hr, 12 hr, 36 hr, 48 hr AFTER DRUG ADMINISTERATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability (like HR ,MAP,RR,SPO2 ,ABG) ,requirement of additional sedation, incidence of adverse events (like hypotension,bradycardia,desaturation ), duration of mechanical ventilaton ,infusion rate |
Baseline, 30 min, 4 hr, 12 hr, 36 hr, 48 hr after drug administeration |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2025 |
| 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
|
|
Brief Summary
|
This prospective observational study compares the sedation efficacy and hemodynamic effects of Dexmedetomidine, Fentanyl, and Midazolam in trauma patients who require emergency intubation and mechanical ventilation. Adult patients meeting the inclusion/exclusion criteria presenting to the Emergency Department and those patients needing intubation and whom sedatives were administered as per Physicians order as part of routine clinical care will be observed and allocated into three groups . Sedation depth, hemodynamic parameters, respiratory variables, and additional sedative requirements are recorded at predefined intervals (Baseline, 30 minutes, 4 hours, 12 hours, 36 hours, and 48 hours). The study aims to determine which agent provides optimal sedation with better hemodynamic stability and fewer adverse effects. Findings are expected to support evidence-based emergency department sedation protocols for intubated trauma patients.The expected outcome will show Dexmedetomidine is a better agent compared to Fentanyl and Midazolam for sedation in mechanically ventilated traumatic patients. Dexmedetomidine also reduced the additional sedation requirement |