| CTRI Number |
CTRI/2024/07/069966 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational Study to understand the Postoperative Sore Throat Rates in Patients After Tube Placement following General Anaesthesia |
|
Scientific Title of Study
|
Analysis of Postoperative Sore Throat Incidence Among Patients Undergoing Various Surgeries Under General Anaesthesia: 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 |
Ankitha |
| Designation |
Postgraduate Student |
| Affiliation |
Yenepoya School of Allied Health Sciences Yenepoya (Deemed to be University) |
| Address |
Department of Anaesthesia and OT Technology Yenepoya School of Allied Health Sciences Yenepoya (Deemed to be University)
Deralakatte Mangalore
Dakshina Kannada
Karnataka
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9902907138 |
| Fax |
|
| Email |
ankithaanchan14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra B V |
| Designation |
Assistant Professor (Department of Anaesthesiology) |
| Affiliation |
Yenepoya Medical College Yenepoya (Deemed to be University) |
| Address |
Department of Anaesthesiology Yenepoya Medical College Yenepoya (Deemed to be University) Deralakatte Mangalore
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880491878 |
| Fax |
|
| Email |
nagendrabv.jois@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagendra B V |
| Designation |
Assistant Professor (Department of Anaesthesiology) |
| Affiliation |
Yenepoya Medical College Yenepoya (Deemed to be University) |
| Address |
Department of Anaesthesiology Yenepoya Medical College Yenepoya (Deemed to be University) Deralakatte Mangalore
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880491878 |
| Fax |
|
| Email |
nagendrabv.jois@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital Yenepoya (Deemed to be University) Deralakatte Mangalore Dakshina Kannada Karnataka India 575018 |
|
|
Primary Sponsor
|
| Name |
Ankitha |
| Address |
Yenepoya School of Allied Health Sciences Yenepoya (Deemed to be University) Mudipu Campus Near Surya Tech Park Kayargoli Kurnad Post Bantwal 575153 |
| 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 |
| Dr Nagendra B V |
Yenepoya Medical College Hospital |
Postoperative ward and Operation Theatre Complex 6th floor and 3rd floor Department of Anaesthesiology Deralakatte Mangalore 575018
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
9880491878
nagendrabv.jois@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing elective surgery under general anaesthesia with ASA 1 & 2 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and female participants aged between 18 and 60years Mallampati score I & II (Airway assessment to assess the mouth opening) American Society of Anaesthesiologists (ASA) Physical status I & II Participants scheduled for elective surgery under general anaesthesia
e. Those who were to remain in the hospital for at least 24 hours postoperatively
|
|
| ExclusionCriteria |
| Details |
Participants posted for emergency surgeries Failure to ETT insertion and estimated surgical time lasts for more than 6 hours Anticipated difficult airway
History of perioperative sore throat
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the expected occurrence and severity of sore throat and assessment of hoarseness among patients undergoing surgeries through endotracheal intubation |
Postoperative Sore Throat and Hoarseness will be assessed by using a standard 4 point scale at three time points(after 1 hour, after 6 hours and after 12 hours postoperatively) [5-6min] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess potential factors such as gender and size of endotracheal tube among patients undergoing surgeries through endotracheal intubation |
Endotracheal Intubation will be done by the anaesthesiologist and Postoperative Sore Throat and Hoarseness will be assessed by using a standard 4 point scale at three time points(after 1 hour, after 6 hours and after 12 hours postoperatively) to assess the factors such as gender and type of endotracheal tube |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In this study "ANALYSIS OF POSTOPERATIVE SORE THROAT INCIDENCE AMONG PATIENTS UNDERGOING VARIOUS SURGERIES UNDER GENERAL ANAESTHESIA: A PROSPECTIVE OBSERVATIONAL STUDY†is a prospective observational study aims to explore the occurrence of post-operative sore throat (POST) and hoarseness in patients undergoing various surgeries under general anaesthesia. The primary objective of the study is to evaluate the incidence and severity of sore throat and hoarseness with secondary objectives, the influence of gender on outcomes. The study design will incorporate an observational study, which will include all patients undergoing elective surgery under general anaesthesia. Written Informed consent will be obtained from all participants. The anaesthesia protocol will adhere to standard practices. Monitoring will encompass standard parameters, and airway management equipment will vary based on the type of surgery. Follow- up assessments will be conducted in the post-anaesthesia care unit (PACU) and 12 hours post- extubation. POST and hoarseness will be assessed using standardized scales. Data will be collected at three time points, including 1st hour, 6th hour, and 12th hour postoperatively.
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