| CTRI Number |
CTRI/2024/08/072501 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to comparatively evaluate budesonide versus fluticasone nebulisation for prevention of post operative sore throat |
|
Scientific Title of Study
|
Comparative Evaluation of Budesonide and Fluticasone nebulisation in preventing 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 |
Tanveer Singh |
| Designation |
Associate Professor |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Anaesthesiology,Dayanand Medical College and Hospital,Tagore nagar, civil lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9872828106 |
| Fax |
|
| Email |
singhtanveer09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manvinder kaur |
| Designation |
Junior resident |
| Affiliation |
Dayanand medical college and hospital |
| Address |
Department of anaesthesiology, Dayanand medical college and hospital, Tagore nagar, civil lines, Ludhiana, 141001
Tagore nagar, civil lines Ludhiana, 141001
Ludhiana
PUNJAB
141001
India |
| Phone |
8968779321 |
| Fax |
|
| Email |
manvindermau@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manvinder kaur |
| Designation |
Junior resident |
| Affiliation |
Dayanand medical college and hospital |
| Address |
Department of anaesthesiology, Dayanand medical college and hospital, Tagore nagar, civil lines, Ludhiana, 141001
Tagore nagar, civil lines Ludhiana, 141001
Ludhiana
PUNJAB
141001
India |
| Phone |
8968779321 |
| Fax |
|
| Email |
manvindermau@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand medical college and hospital, Tagore nagar, Civil lines, Ludhiana, Punjab, India
141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana, 141001 |
| Type of Sponsor |
Private 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 Manvinder Kaur |
Dayanand Medical College and Hospital |
Department of Anaesthesiology, Dayanand medical college and hospital,Tagore nagar, civil lines, Ludhiana, 141001
Ludhiana
PUNJAB |
8968779321
manvindermau@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical comittee,Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative evaluation of Budesonide and fluticasone nebulisation in preventing post operative sore throat |
Patients in Group B will be nebulised with Budesonide 500 mcg diluted to 5ml, for 20 minutes, 15 minutes before induction of anaesthesia |
| Intervention |
Comparative evaluation of budesonide and fluticasone nebulisation in preventing post operative sore throat |
Patients in Group F will be nebulised with fluticasone 500 mcg diluted to 5ml, for 20 minutes, 15 minutes before induction of anaesthesia |
| Comparator Agent |
Comparative evaluation of Budesonide and fluticasone nebulisation in preventing post operative sore throat |
Patients in group S will be nebulised with 5ml normal saline, for 20 minutes, 15 minutes before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- Adult patient of age group 18 to 70 years.
- American Society of Anaesthesiology (ASA) physical status (PS) 1,2,3
- BMI less than 35kg/m2.
- Scheduled to undergo elective surgery lasting more than 2 hours, under General Anaesthesia (GA) using Endotracheal Tube (ETT).
|
|
| ExclusionCriteria |
| Details |
- Patients who are uncooperative and unwilling to take part in study
-Patient with history of preoperative sore throat or upper respiratory tract infection
- Known allergy to budesonide or fluticasone
- Patient already on budesonide or fluticasone treatment
-Pregnant or lactating mothers
-History of COPD or Asthma
-Mallampati grade greater than 2
-Surgeries in prone position
- Patients undergoing day care, bariatric, cardiac, nasal, oral, head and neck surgeries
- Patient requiring throat pack
-Obese patients BMI greater than 35kg/m2
- Patients with history of use of steroids or NSAIDS within 24 hrs of surgery
-Patients having psychiaric illness and communication difficulties |
|
|
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 |
| To compare incidence, severity and duration of sore throat in all 3 groups |
To compare incidence, severity and duration of sore throat at post op hours 0, 2, 4, 8, 12, 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare occurance of postextubation cough and hoarseness of voice in all 3 groups
2. To compare side effect profile of both the drugs |
hoarseness of voice postoperatively at 0hour, 2hours, 4hours, 8hours,12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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)
|
22/08/2024 |
| 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
|
A prospective, randomized, double blind clinical study will be conducted on total of 159 patients divided into 3 groups of 53 each.Patients aged 18 to 70 years, ASA grade 1-3 and patient undergoing elective surgery under general anaesthesia, lsting greater than 2hours and requiring endotracheal tube and ryle’s tube insertion , will be included in the study. Group B patients will be nebulised with budesonide 500 mcg diluted to 5ml, Group F patients will be nebulised with fluticasone 500 mcg diluted to 5ml and Group S will be nebulised with 5ml Normal saline. Post operative sore throat, cough grade, pain score and hoarseness of voice will be assessed at postoperative period of 0,2,4,8,12 and 24 hours. Data thus collected will be statistically analyzed. |