| CTRI Number |
CTRI/2026/01/101837 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING THE EFFECT OF EXPOSURE TO INHALED BUDESONIDE VERSUS FLUTICASONE PROPIONATE IN PARTICIPANTS UNDERGOING ELECTIVE INTUBATION ON POST OPERATIVE SORE THROAT, COUGH, AND HOARSENESS OF VOICE |
|
Scientific Title of Study
|
COMPARING THE EFFICACY OF INHALED BUDESONIDE SUSPENSION VERSUS INHALED FLUTICASONE PROPIONATE ADMINISTERED USING A METERED DOSE INHALER, ON POST- OPERATIVE SORE THROAT, HOARSENESS OF VOICE AND COUGH AN OBSERVATIONAL 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 |
Rinka Pal |
| Designation |
Junior Resident-2 |
| Affiliation |
Grant Government Medical college and Sir J J Hospital. |
| Address |
Department of anaesthesia, J J Hospital campus. Bycualla 400008
Department of anaesthesia, J J Hospital campus. Bycualla 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8390719333 |
| Fax |
|
| Email |
rinka.pal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukriti Atram |
| Designation |
Associate Professor |
| Affiliation |
Grant Government Medical college and Sir J J Hospital. |
| Address |
Department of Anaesthesiology, Grant Government Medical college and Sir J J Hospital.
Department of Anaesthesiology, Grant Government Medical college and Sir J J Hospital.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukriti Atram |
| Designation |
Associate Professor |
| Affiliation |
Grant Government Medical college and Sir J J Hospital. |
| Address |
Department of Anaesthesiology, Grant Government Medical college and Sir J J Hospital.
Department of Anaesthesiology, Grant Government Medical college and Sir J J Hospital.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Grant Government Medical College and Sir J J Hospital, Byculla Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
DrRinka Pal |
| Address |
Department of anaesthesia, J J Hospital campus. Bycualla 400008 |
| 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 |
| Rinka Pal |
Grant Government Medical College and Sir J J Hospital, |
Department of anaesthesia.
Mumbai
MAHARASHTRA |
08390719333
rinka.pal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committe, Grant Government Medical College,Mumbai 400008e |
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 |
| Comparator Agent |
INHALED BUDESINIDE MDI |
COMPARING THE EFFICASY ON POST ENDOTRACHEAL INTUBATION ON POST OPERATIVE SORE THROAT, HOARSENESS OF VOICE AND COUGH |
| Intervention |
INHALED FLUTICASONE PROPIONATE MDI |
COMPARING THE EFFICASY ON POST ENDOTRACHEAL INTUBATION ON POST OPERATIVE SORE THROAT, HOARSENESS OF VOICE AND COUGH |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I (healthy patients) and II (mild to moderate systemic disease but medically well controlled).
Patients posted for elective surgeries in Operation theater.
Patients who are MPC 1(complete visualization of uvula)) or 2 (uvula partly visible) as assessed by a senior anesthetist.
|
|
| ExclusionCriteria |
| Details |
Patients with known allergy to corticosteroid.
Patients who are not willing to participate in this study.
Patients with pre-existing cardiovascular, renal and hepatic disorders.
Patients who have difficult airways as assessed by a senior anesthetist (obese (BMI MORE THAN 30 kg/meter sq), distorted airways.
Patients who are anticipated difficult intubation.
Patients already on analgesic or steroids (systemic or inhaled).
Patients with pre-operative sore throat.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECTIVENESS OF INHALED BUDESONIDE SUSPENSION VERSUS INHALED FLUTICASONE PROPIONATE (ADMINISTERED VIA METERED-DOSE INHALER) IN REDUCING THE INCIDENCE AND SEVERITY OF POST-OPERATIVE SORE THROAT (POST). |
ASSESSED AT BASELINE (POST EXTUBATION), 2HOURS, 4 HOURS, 6 HOURS, 12HOURS, AND AT 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE EFFECT OF INHALED BUDESONIDE AND INHALED FLUTICASONE PROPIONATE ON THE HEMODYNAMIC CHANGES |
ASSESSED AT BASELINE AFTER INDUCTION, POST INDUCTION, 15 MINUTES, 30 MINUTES, 45 MINUTES, 60 MINUTES, 90 MINUTES,120 MINUTES, BEFORE EXTUBATION, IMMEDIATELY POST EXTUBATION. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
10/12/2026 |
| 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="0"
Months="8"
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 COMPARATIVE STUDY IS DESIGNED TO ASSESS AND COMPARE THE EFFICACY OF INHALED BUDESONIDE SUSPENSION (200 MCG) AND INHALED FLUTICASONE PROPIONATE (150 MCG) DELIVERED VIA A METERED-DOSE INHALER 10 MINUTES PRIOR TO ENDOTRACHEAL INTUBATION, IN REDUCING THE INCIDENCE AND SEVERITY OF POST-OPERATIVE SORE THROAT, COUGH, AND HOARSENESS OF VOICE IN PATIENTS UNDERGOING GENERAL ANAESTHESIA. A TOTAL OF 104 PATIENTS WITH ASA PHYSICAL STATUS I–II, AGED 18–60 YEARS, WILL BE RANDOMLY ASSIGNED TO TWO GROUPS. POST-OPERATIVE SORE THROAT, COUGH, AND HOARSENESS WILL BE EVALUATED AT 2, 4, 6, 12, AND 24 HOURS FOLLOWING SURGERY USING STANDARDIZED GRADING CRITERIA. HEMODYNAMIC VARIABLES AND ANY DRUG-RELATED ADVERSE EFFECTS WILL ALSO BE MONITORED AND DOCUMENTED. THE STUDY IS ANTICIPATED TO DEMONSTRATE THAT BOTH INHALED CORTICOSTEROIDS ARE EFFECTIVE IN REDUCING AIRWAY-RELATED POST-OPERATIVE COMPLICATIONS, WITH EITHER SIMILAR EFFICACY OR A STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE TWO AGENTS. THE FINDINGS MAY HELP DETERMINE A SAFE AND EFFECTIVE PROPHYLACTIC INTERVENTION FOR MINIMIZING POST-INTUBATION AIRWAY MORBIDITY. |