| CTRI Number |
CTRI/2024/11/076827 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurrence of sore throat with and without throat pack in nasal surgeries |
|
Scientific Title of Study
|
Occurrence of sore throat with and without throat pack in nasal surgeries: A prospective 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 |
Dinesh N |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology, K S Hegde Medical Academy, Deralakatte post, Mangaluru
Dakshina Kannada
Karnataka
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7483082621 |
| Fax |
|
| Email |
dineshnandakumar05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siri Kandavar |
| Designation |
Associate Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology, Justice K S Hegde Charitable Hospital, Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
Karnataka
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9739868002 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh N |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology, K S Hegde Medical Academy, Deralakatte post, Mangaluru
Dakshina Kannada
Karnataka
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7483082621 |
| Fax |
|
| Email |
dineshnandakumar05@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Deralakatte, Mangaluru,
Karnataka,
India
575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte, Mangaluru, Karnataka India 575018 |
| 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 Siri Kandavar |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology and Critical Care
Dakshina Kannada
KARNATAKA |
9739868002
sirikandavar16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde Medical Academy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing elective nasal surgery under general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
pediatrics, emergency surgery, pregnancy, patients with history of sore throat in last 2 weeks and with acid peptic disorders, multiple attempts of endotracheal tube insertion, uncontrolled hypertensive patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the occurrence of sore throat in patients undergoing nasal surgery with and without use of throat pack |
48 hours in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO observe the severity and factors causing the sore throat |
48 hours in the postoperative period |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
26/11/2024 |
| 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="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
|
This study is conducted to assess the occurrence of sore throat among the patients undergoing nasal surgery with or without use of throat pack .Sore throat can be due to many reasons .We want to see if throat pack can also lead to sore throat. |