| CTRI Number |
CTRI/2024/07/071477 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To know the effect of aspirin tablet gargling on sore throat incidence |
|
Scientific Title of Study
|
Effect Of Aspirin Gargle on Postoperative Sore Throat In Patients Undergoing Middle Ear Surgery Under 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 |
DR Soundarya |
| Designation |
Postgraduate student |
| Affiliation |
ESIC MC PGIMSR MH RAJAJINAGAR BANGALORE |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
Bangalore
KARNATAKA
560010
India |
| Phone |
9663431064 |
| Fax |
080-23325130 |
| Email |
drsoundaryarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G B Sumalatha |
| Designation |
professor |
| Affiliation |
ESIC MC PGIMSR MH RAJAJINAGAR BANGALORE |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
KARNATAKA
560086
India |
| Phone |
9663431064 |
| Fax |
080-23325130 |
| Email |
gbsumaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G B Sumalatha |
| Designation |
Professor |
| Affiliation |
ESIC MC PGIMSR MH RAJAJINAGAR BANGALORE |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
KARNATAKA
560010
India |
| Phone |
9663431064 |
| Fax |
080-23325130 |
| Email |
gbsumaravi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Employees State Insurance Corporation Medical College Bangalore |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology , 560086 |
| 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 G B SUMALATHA |
ESIC Postgraduate Institue of Medical Scienses and medical hospital |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology , 560086
Bangalore
KARNATAKA |
09538301444
080-23325130
gbsumaravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aspirin gargle 325 mg |
The study patients received 325 mg aspirin gargle before the start of surgery |
| Comparator Agent |
normal saline |
patiets received normal saline gargle before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give informed written consent.
Elective middle ear surgical procedures with oral-tracheal intubation.
American Society of Anesthesiologists (ASA) class I-II.
Duration of surgery less than 4 hours.
Aged between 18-60 years of either gender.
|
|
| ExclusionCriteria |
| Details |
Patient not willing to give informed consent. Patients with history of preoperative sore throat.
History or anticipated difficult intubation. Patients requiring more than one attempt at intubation. History of Aspirin allergy or hypersensitivity.
6. Patient requiring the insertion of a nasogastric tube.
7. History of asthma and chronic obstructive pulmonary disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of preoperative aspirin gargle 325mg on postoperative sore-throat in patients scheduled for elective middle ear surgeries under general anaesthesia with oral endotracheal intubation with respect to,
• Postoperative sore-throat
Cough
Hoarseness of voice |
t 1 - after one hour of surgery
t 2 - 4 hour of surgery
t3 - 8h ours after surgery
t 4 - 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction of post operative experience at 24 hrs between the two groups receiving aspirin gargle and normal saline gargle. |
T2 at postoperative 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
14/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
Post operative sore throat is a common complaint after general anesthesia associated with endotracheal intubation. There have been many drugs studied to reduce the incidence of sore throat . newer drugs include Aspirin gargle which can reduce the incidence and severity of sore throat when used before surgery . |