| CTRI Number |
CTRI/2023/07/055651 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of budesonide inhaler with nebuliser in postoperative sore throat |
|
Scientific Title of Study
|
A randomised,prospective and unblinded manner clinical trial to compare the effect of inhaled budesonide suspension with budesonide nebuliseron severity of postoperative sorethroat subsequent to endotracheal intubation
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandita Kad |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9896335544 |
| Fax |
|
| Email |
kadnandita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay jaswal |
| Designation |
Junior resident |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7973339709 |
| Fax |
|
| Email |
akshayjaswal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Jaswal |
| Designation |
Junior Resident |
| Affiliation |
PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7973339709 |
| Fax |
|
| Email |
akshayjaswal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma University of Health Sciences PGIMS, Rohtak, Haryana |
| Address |
Pt B D Sharma University of Health Sciences PGIMS, Rohtak, Haryana |
| 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 Akshay Jaswal |
Pt B D Sharma PGIMS,Rohtak |
Department of Anaesthesiology and Critical Care,PGIMS
Rohtak
HARYANA |
7973339709
akshayjaswal1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt BD Sharma PGIMS Rohtak |
Approved |
|
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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 |
For postoperative sore throat subsequent to endotracheal intubation |
Comparison of effect of inhaled budesonide suspension with metered dose inhaler (200mcg/puff)and nebuliser (0.5mg) in postoperative sore throat subsequent to endotracheal intubation |
| Comparator Agent |
To compare the effect of inhaled budesonide suspension with budesonide nebuliser in postoperative sore throat subsequent to endotracheal intubation |
Comparative evaluation of the effect of inhaled budesonide suspension (200mcg) with budesonide nebuliser(0.5mg) in postoperative sore throat subsequent to endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA 1-2 with MPG 1-2 undergoing surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway, history of allergy to test drug,active preoperative sore throat,analgesics and corticosteroids in treatment regime,history of fluid retention, history of delayed wound healing, history of glucose intolerance,laparoscopic surgeries ,duration of surgery < 60min or >180min, refusal to participate in the study will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of inhaled budesonide suspension with metered dose inhaler and nebulisation on severity of sore throat at an intervals of 0hrs, 6hrs, 24hrs postoperatively |
To compare the effect of inhaled budesonide suspension with metered dose inhaler and nebulisation on severity of sore throat at an intervals of 0hrs, 6hrs, 24hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For postoperative sore throat subsequent to endotracheal intubation |
For postoperative sore throat subsequent to endotracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/08/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A prospective, comparative, randomised and unblinded study will be conducted in patients of either sex of age 18-60 years ,belonging to American Society of Anesthesiologists (ASA) physical status of I-II with mallampati grading of I-II undergoing surgeries under general anaesthesia.Patients with anticipated difficult airway,history of allergic to test drug ,active preoperative sore throat, analgesics and corticosteroids (inhaled or systemic) in treatment regime, history of fluid retention, history of delayed wound healing, history of glucose intolerance, patients undergoing laparoscopic surgeries, duration of surgery less than 60min or more than 180min, refusal to participate in the study will be excluded from the study.Patients will be randomly allotted to one of the two groups according to computer generated list. Group I will recieve 200mcg budesonide inhalation suspension 30min before Intubation which will be repeated 6hrs after extubation and group N will recieve 0.5mg of budesonide respule via nebulisation 30min before intubation which will be repeated 6hrs after the extubation. Postoperative sore throat grade and postoperative hoarseness of voice grade will be noted at 2hr, 6hr, 24hr post extubation. Data will be analysed using appropriate statistical methods. |