| CTRI Number |
CTRI/2025/10/096702 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [comparator ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Which is better for preventing sore throat after surgery – nebulized dexamethasone or breathing tube cuff dexamethasone |
|
Scientific Title of Study
|
A study to compare the efficacy of nebulized versus intracuff dexamethasone for prevention of post operative sore throat |
| 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 KARTIK SAINI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRMS IMS BAREILLY |
| Address |
DEPARTMENT OF ANAESTHESIA SHRI RAM MURTI SMARAK INSTITUTE OF MEDICAL SCIENCES BAREILLY
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9466353208 |
| Fax |
|
| Email |
kartiksainiks7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VISHWADEEP SINGH |
| Designation |
PROFESSOR |
| Affiliation |
SRMS IMS BAREILLY |
| Address |
DEPARTMENT OF ANAESTHESIA SHRI RAM MURTI SMARAK INSTITUTE OF MEDICAL SCIENCES BAREILLY
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
992777008 |
| Fax |
|
| Email |
VISHWADEEPVISHEN@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
AKHILESH PAHADE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRMS IMS BAREILLY |
| Address |
DEPARTMENT OF ANAESTHESIA SHRI RAM MURTI SMARAK INSTITUTE OF MEDICAL SCIENCES BAREILLY
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9818128778 |
| Fax |
|
| Email |
AKHILDADA09@YAHOO.IN |
|
|
Source of Monetary or Material Support
|
| SHRI RAM MURTI SMARAK INSTITITE OF MEDICAL SCIENCES BHOJIPURA BAREILLY UTTAR PRADESH 243202 |
|
|
Primary Sponsor
|
| Name |
SRMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHRI RAM MURTI SMARAK INSTITITE OF MEDICAL SCIENCES BHOJIPURA BAREILLY UTTAR PRADESH 243202 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 KARTIK SAINI |
SRMS INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIA SHRI RAM MURTI SMARAK INSTITUTE OF MEDICAL SCIENCES BAREILLY
Bareilly
UTTAR PRADESH |
9466353208
kartiksainiks7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
LARYNGOTRACHEAL INFLAMATION SECONDARY TO ENDOTRACHEAL INTUBATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRACUFF DEXAMETHASONE |
PATIENT RECIEVED DEXAMETHASONE (8MG) 2ML MIXED WITH 3ML NORMAL SALINE IN ENDOTRACHEAL TUBE CUFF |
| Comparator Agent |
NEBULIZED DEXAMETHASONE |
PATIENT RECIEVED DEXAMETHASONE(8MG) 2ML MIXED WITH 3ML OF NORMAL SALINE FOR NEBULIZATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT AGED 18-60 YEARS OF EITHER SEX ,
ASA GRADE 1 AND 2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)TO COMPARE THE INCIDENCE AND SEVERITY OF POST OPERATIVE SORE THROAT BETWEEN BOTH THE GROUPS |
PATIENTS WERE ASSESSED FOR POSTOPERATIVE SORE THROAT AT VARIOUS TIME INTERVALS, SPECIFICALLY JUST AFTER EXTUBATION AND THEN AT 0, 2, 4, 8, 12, 18, AND 24 HOURS, USING A STANDARDIZED ASSESSMENT TABLE.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) TO COMPARE THE INCIDENCE AND SEVERITY OF POST OPERATIVE HOARSNESS OF VOICE BETWEEN BOTH THE GROUPS.
2)TO COMPARE THE INCIDENCE AND SEVERITY OF POST OPERATIVECOUGH BETWEEN BOTH THE GROUPS |
PATIENTS WERE ASSESSED FOR POSTOPERATIVE SORE THROAT AT VARIOUS TIME INTERVALS, SPECIFICALLY JUST AFTER EXTUBATION AND THEN AT 0, 2, 4, 8, 12, 18, AND 24 HOURS, USING A STANDARDIZED ASSESSMENT TABLE. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="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
|
TO COMPARE THE EFFECTIVENESS OF NEBULIZED DEXAMETHASONE VERSUS INTRACUFF DEXAMETHASONE IN REDUCING THE INCIDENCE AND SEVERITY OF POSTOPERATIVE SORE THROAT. IT AIMS TO DETERMINE THE MORE EFFICIENT ROUTE OF ADMINISTRATION FOR AIRWAY-RELATED COMPLICATIONS AFTER GENERAL ANESTHESIA. |