| CTRI Number |
CTRI/2025/12/098630 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study on Reducing Post-Anesthesia Sore Throat with Low-Dose Dexamethasone Nebulization |
|
Scientific Title of Study
|
A Randomized Controlled Trial: Evaluating low dose Nebulized Dexamethasone in decreasing the incidence of Postoperative Sore Throat in Patients Undergoing 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 |
Kumari Sneha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9818234861 |
| Fax |
|
| Email |
kumari.anesth@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kumari Sneha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9818234861 |
| Fax |
|
| Email |
kumari.anesth@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kumari Sneha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
department of Anaesthesia,AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9818234861 |
| Fax |
|
| Email |
kumari.anesth@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani,saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal 741245 |
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal 741245 |
| 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 Kumari Sneha |
AIIMS Kalyani |
department of Anaesthesia, IPD Building AIIMS Kalyani,Saguna,NH-34 Connector,Basantapur,Kalyani,west Bengal
Nadia
WEST BENGAL |
09818234861
kumari.anesth@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: NA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | NORMAl saline | in control group Patients will receive 5 mL of normal saline nebulized.
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dexamethasone, Reference: allopathy, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(mg), Frequency: od, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: in intervention group Patients will receive 4 mg dexamethasone mixed with 4 mL of normal saline nebulized.
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients classified as ASA I or II.Patients scheduled for elective surgeries requiring general anesthesia and endotracheal intubation.Expected surgery duration of less than 3 hours.Anticipated single-attempt intubation with a Mallampati score of 3 and 4 without any active airway infection or chronic respiratory conditions
|
|
| ExclusionCriteria |
| Details |
1. History of recent upper respiratory tract infection ,sore throat, chronic cough, or airway-related surgeries.Known hypersensitivity to corticosteroids or nebulization agents.Obesity with BMI more than 35 Pregnancy or lactation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of Post operative sore throat. |
postoperative sore throat (POST) will be assessed at 0, 2, 8, 12, and 24 hours post-extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : Assess the severity of POST and associated complications such as hoarseness and cough |
Baseline
Just after intubation
Post extubation(0hrs)
Post extubation(2hrs)
Post extubation(8hrs)
Post extubation(12hrs)
Post extubation(24hrs)
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
24/12/2025 |
| 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="2"
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 randomized controlled trial aims to assess whether low dose nebulized dexamethasone can reduce the incidence and severity of postoperative sore throat POST in patients undergoing general anaesthesia with endotracheal intubation. POST is a frequent and unpleasant complication caused mainly by airway irritation from the endotracheal tube, high cuff pressure, prolonged intubation, and dryness of airway mucosa. Although self-limiting, POST affects patient comfort and satisfaction. Dexamethasone is known for its anti-inflammatory effects and is commonly used intravenously to reduce POST. Nebulized dexamethasone offers the advantage of direct airway delivery with fewer systemic effects. The study will be a prospective, randomized, double blind, controlled trial conducted over 12 months in the operation theatre and postoperative recovery area of AIIMS Kalyani. Adult patients aged 18 to 65 years, classified as ASA 3 or 4 and scheduled for elective surgeries under general anaesthesia with an expected intubation duration of less than 3 hours, will be included. Patients with recent respiratory infection, chronic airway disease, steroid allergy, obesity, pregnancy, smoking history, head and neck surgery, or difficult airway conditions will be excluded. A total of 72 patients will be enrolled based on sample size calculation. Participants will be randomly allocated into two groups. Group D will receive 4 mg dexamethasone in 4 mL saline via nebulization, while Group S will receive 5 mL normal saline. Nebulization will be performed 30 minutes before induction. A uniform anaesthesia protocol will be followed for all patients. Cuff pressure will be maintained at 20 to 22 cm H2O. POST will be assessed at 0, 2, 8, 12, and 24 hours after exudation by blinded assessors using a 4-point severity scale. Secondary outcomes such as hoarseness and cough will also be recorded. Data will be analysed using appropriate statistical tests with significance set at P less than 0.05. Ethical approval and written informed consent will be obtained before study initiation. |