| CTRI Number |
CTRI/2026/02/104228 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two medicines, Dexmedetomidine and fentanyl to help patients wake up and recover calmly and smoothly after general anaesthesia |
|
Scientific Title of Study
|
Comparative study between intravenous Dexmedetomidine and intravenous fentanyl for smooth extubation and Emergence after 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 |
Aadhya bajaj |
| Designation |
PG Resident 1st Year |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex
Department of Anaesthesiology
Mahatma Gandhi Medical College and Hospital,
Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9810123030 |
| Fax |
|
| Email |
Draadhyabajaj19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vigya Goyal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex OT No 1 Plastic Surgery OT
Department of Anaesthesiology
Mahatma Gandhi Medical College and Hospital,
Sitapura, Jaipur
Department of Anaesthesiology
Jaipur
RAJASTHAN
302022
India |
| Phone |
8349249511 |
| Fax |
|
| Email |
goyalvigya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vigya Goyal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
2nd Floor OT Complex OT No 1 Plastic Surgery OT
Department of Anaesthesiology
Mahatma Gandhi Medical College and Hospital,
Sitapura, Jaipur
Department of Anaesthesiology
Jaipur
RAJASTHAN
302022
India |
| Phone |
8349249511 |
| Fax |
|
| Email |
goyalvigya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Main OT complex 2nd floor Department of Anaesthesiology Mahatma Gandhi Medical College and Hospital Sitapura Jaipur ,India
Pincode - 302022 |
| 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 aadhya bajaj |
Mahatma Gandhi hospital , Jaipur |
Main OT complex 2nd floor department of Anaesthsia Mahatma Gandhi medical college and hospital jaipur Rajasthan
Jaipur
RAJASTHAN |
9810123030
Draadhyabajaj19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective surgery under general anaesthesia with duration upto 3hrs
2. Patients with ASA class I and class II |
|
| ExclusionCriteria |
| Details |
1. Smoking history
2. Cough
3. History of drug allergy with either of the study drugs
4. More than two intubation attempts
5. Preoperative sore throat
6. Surgery involving airway
7. Difficult airway
8. Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of intravenous Dexmedetomidine vs intravenous fentanyl for smooth extubation and Emergence after general anaesthesia |
Peri operative monitoring of vitals that is pre induction , post induction, intra operative and post operative post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain in both groups. |
Post extubation followed by 1hr, 2hr, 4hrs, 6hrs & 12hrs |
| To compare post operative adverse events such as nausea, vomiting, laryngospasm & bronchospasm in both the groups. |
Post operative every 2 hours upto 12 hours |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
02/03/2026 |
| 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 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
|
This prospective randomized comparative study will evaluate intravenous dexmedetomidine versus intravenous fentanyl for smooth extubation and emergence after general anesthesia. This study aims to compare the quality of extubation and hemodynamic responses during emergence. Secondary outcomes include emergence time, sedation score, postoperative pain, and adverse effects. The objective is to determine the safer and more effective drug for achieving smooth extubation and stable recovery. |