| CTRI Number |
CTRI/2025/05/087989 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two ways of using dexamethasone to reduce sore throat after surgery |
|
Scientific Title of Study
|
Effect of nebulized vs intracuff dexamethasone on 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 |
Shalu kushwaha |
| Designation |
Anaesthesia residents |
| Affiliation |
Pt. JNM medical college |
| Address |
Department of Aanaesthesia and Pain Medicine Pt. JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7440935927 |
| Fax |
|
| Email |
shalukushwaha505@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rashmi Naik |
| Designation |
Associate professor |
| Affiliation |
Pt. JNM medical college |
| Address |
Department of Aanaesthesia and Pain Medicine Pt. JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7024558098 |
| Fax |
|
| Email |
rashminaik.2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalu kushwaha |
| Designation |
Anaesthesia residents |
| Affiliation |
Pt. JNM medical college |
| Address |
Department of Aanaesthesia and Pain Medicine Pt. JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7440935927 |
| Fax |
|
| Email |
shalukushwaha505@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Pain Medicine Pt. JNM Medical College, opposite jail Road Raipur Chhattisgarh, India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Pain Medicine Pt.JNM Medical College Raipur |
| Address |
in front of central jail moudhapara Raipur C.G. |
| Type of Sponsor |
Government 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 Shalu kushwaha |
Dr. Bhim Rao Ambedkar Memorial Hospital |
Major OT complex 2nd floor Department of Aanaesthesia and Pain Medicine Pt. JNM Medical College Raipur
Raipur
CHHATTISGARH |
7440935927
shalukushwaha505@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Pt.JNM medical college raipur |
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 |
Effect of intracuff vs nebulized dexamethasone on post operative sore throat |
After thorough history taking and examination patients who meet the inclusion criteria will be randomly allocated into two group A and group B Group A receive dexamethasone nebulization 15 min before induction. Group B intracuff dexamethasone till no audible leak is heard on auscultation. Then incidence of post operative sore throat, hoarseness and cough will be assessed at different time interval |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
MPG grade 1 and 2
Surgery in supine position under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patient refusal
Pregnancy
Known allergy with study drug
Preexisting laryngeal and pharyngeal disease
Patients requiring orogastric tube insertion
Patient undergoing oropharyngeal surgery
Patients on steroids or NSAIDs
Patients with severe GERD
Patients having sore throat
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of post operative sore throat with intracuff vs nebulized dexamethasone |
At 2hr,6hr, 12hr and 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the severity of POST with intracuff vs nebulized dexamethasone
To compare the incidence & severity of post op hoareseness with intracuff vs nebulized dexamethasone
To compare the incidence & severity of post op cough with intracuff vs nebulized dexamethasone |
At 2hr 6hr 12hr 24hr |
|
|
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 4 |
|
Date of First Enrollment (India)
|
03/06/2025 |
| 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 is the randomized interventional study comparing nebulized dexamethasone vs intracuff dexamethasone for prevention of sore throat. Patients requiring endotracheal intubation will enrolled with sample size of 60 (30 in each group). Primary outcome will be the incidence of sore throat with nebulized vs intracuff dexamethasone. secondary outcome will be severity of post operative sore throat, incidence and severity of post op hoarseness and incidence and severity of post op cough with nebulized vs intracuff dexamethasone. Assessment will be done on 2hr,6hr,12hr and 24hr in post op period. |