| CTRI Number |
CTRI/2025/08/093390 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two different combinations for giving anaesthesia in short surgeries |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and ketamine versus fentanyl and propofol for short surgical procedures under general anaesthesia |
| 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 R Brindha |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Mohamed Asiq |
| Designation |
Post Graduate Resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9940051899 |
| Fax |
|
| Email |
m.mohamedasiq@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Kirubanandha Variyar Medical College And Hospital Salem Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Chinna Seeragapadi, Salem – 636 308, Tamil Nadu, India |
| 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 |
| Dr M Mohamed Asiq |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU |
9940051899
m.mohamedasiq@gmail.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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of Dexmedetomidine and ketamine versus fentanyl and propofol |
Comparison of Dexmedetomidine and ketamine versus fentanyl and propofol for short surgical procedures under general anaesthesia |
| Intervention |
Dexmedetomidine and ketamine |
for short surgical procedures under general anaesthesia |
| Intervention |
fentanyl and propofol |
for short surgical procedures under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 - 60 years (Both Males and Females)
ASA Grade 1 and 2
Undergoing Short Surgical Procedures (less than 60 mins) |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA grade 3 and 4
Posted for Emergency Surgeries
Allergy to Propofol and dexmedetomidine
CVS Disorders
Liver or Renal Dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of dexmedetomidine and ketamine versus fentanyl and propofol for intraoperative analgesia and anaesthesia and to assess hemodynamic stability |
From 15 mins to 1 hour Intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative recovery profiles including emergence time,sedation,pain score & incidence of postoperative nausea & vomiting between dexmedetomidine & ketamine & fentanyl & propofol groups |
From 15 mins to 6 hour postoperatively in PAICU |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/09/2025 |
| 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="0"
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 Study Compares Dexmedetomidine and ketamine versus fentanyl and propofol for short surgical procedures under general anaesthesia |