| CTRI Number |
CTRI/2026/01/101897 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find out which drug among nebulised dexamethasone, nebulised magnesium sulphate, nebulised lidocaine is effective in decreasing sore throat that occurs post-operatively in patients undergoing Cortical Mastoidectomy and Modified Radical Mastoidectomy under general anesthesia |
|
Scientific Title of Study
|
Effectiveness of nebulised Dexamethasone,Magnesium sulphate,and Lidocaine in attenuating post-operative sore throat in patients undergoing Modified Radical Mastoidectomy and Cortical Mastoidectomy under general anaesthesia-A Double-blinded Randomised Comparative Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnushna Kar |
| Designation |
Post-Graduate Resident |
| Affiliation |
Institute of Medical Sciences and Sum Hospital |
| Address |
Institute Of Medical Sciences and Sum Hospital, K-8,Kalinganagar,Near Sampur,Bhubaneswar,Odisha
Khordha
ORISSA
751003
India |
| Phone |
9123301315 |
| Fax |
|
| Email |
anushnakar1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sushree Das |
| Designation |
Professor,Department of Anesthesiology |
| Affiliation |
Institute of Medical Sciences and Sum Hospital |
| Address |
Institute Of Medical Sciences and Sum Hospital, K-8,Kalinganagar,Near Sampur,Bhubaneswar,Odisha
Khordha
ORISSA
751003
India |
| Phone |
9132425105 |
| Fax |
|
| Email |
das.sushri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnushna Kar |
| Designation |
Post-Graduate Resident |
| Affiliation |
Institute of Medical Sciences and Sum Hospital |
| Address |
Institute Of Medical Sciences and Sum Hospital, K-8,Kalinganagar,Near Sampur,Bhubaneswar,Odisha
Khordha
ORISSA
751003
India |
| Phone |
9123301315 |
| Fax |
|
| Email |
anushnakar1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences and Sum Hospital,Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
DrAnushna Kar |
| Address |
Institute of Medical Sciences and Sum Hospital,K-8,Kalinganagar,Bhubaneswar,Odisha, 751003 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAnushna Kar |
Institute Of Medical Sciences and Sum Hospital |
Departmentof Anaesthesiology,
K-8,
Kalinganagar,Bhubaneswar,Odisha
Khordha
ORISSA |
9123301315
anushnakar1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)Nebulised Dexamethasone |
2ml Dexamethasone (4mg)+ 3ml NS=5ml given in nebulised form for 18 months |
| Comparator Agent |
2)Nebulised Magnesium Sulphate |
2.5ml Magnesium sulphate(250mg) + 2.5ml NS=5mlgiven in nebulised form for 18 months |
| Intervention |
3)Nebulised Lidocaine |
2% of 5ML =100 mg given in nebulised form for 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age(18-60 years),
2)Gender(both male and female)
3)ASA(grade 1,2)
4)Posted for elective MRM,CM(under general anaesthesia)
|
|
| ExclusionCriteria |
| Details |
Patients with :
1)Pre-existing sore throat
2)Recent upper respiratory infection
3)Known drug allergy
4)Anticipated difficult airway
5)Pregnancy
6)COPD
7)Needed more than 1 intubation attempt
8)Developed intra-op or post-op complication.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To examine the effectiveness of dexamethasone,magnesium sulfate,and lidocaine nebulisation in attenuating POST in adult patient undergoing modified radical mastoidectomy and cortical mastoidectomy under general anaesthesia
|
Post-operative sore throat assessed at 0,2,8,12,24 hours from time of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe for hoarseness & cough post-operatively
|
Observed 8th hourly for 24 hours Post-operative
|
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
01/03/2026 |
| 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 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 prospective,randomised,double-blinded study performed in our tertiary care centre will have 102 participants(34 each group-D,M,l).Group D will be given Nebulised Dexamethasone,Group M will be given Nebulised Magnesium Sulpahte and group L will be given Nebulised Lidocaine via wall-attached oxygen driven nebulisation mask.The primary investigator in post-anaesthetic care unit who is unaware of randomisation of groups will assess sore throat at 0,2,8,12,24 hours respectively from time of extubation via a scale.Hemodynamic variables like Heart rate,systolic blood pressure,diastolic blood pressure will be monitored. |