| CTRI Number |
CTRI/2023/06/054022 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE RANDOMISED DOUBLE BLIND STUDY - PREOPERATIVE NEBULIZATION WITH KETAMINE AND DEXMEDETOMIDINE ON THE INCIDENCE OF POSTOPERATIVE SORE THROAT |
|
Scientific Title of Study
|
A COMPARATIVE DOUBLE BLIND STUDY - PREOPERATIVE NEBULIZATION WITH KETAMINE AND DEXMEDETOMIDINE ON THE INCIDENCEOF POSTOPERATIVE SORE THROAT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMLAN MOHANTY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BHARATI HOSPITAL AND RESEARCH CENTRE, PUNE |
| Address |
Department of anaesthesia, bharati hospital, bharati vidyapeeth, pune, maharashtra
room no 204, Pg medical boys hostel, Bharati hospital and research centre, pune, maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9040597442 |
| Fax |
|
| Email |
aamlanmohanty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Swami |
| Designation |
Professor, Department of Anaesthesia |
| Affiliation |
Bharati hospital and research center, pune |
| Address |
Department of anaesthesia, bharati hospital, bharati vidyapeeth, pune, maharashtra
Bharati vidyapeeth, pune, maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9822846369 |
| Fax |
|
| Email |
drswamisarita@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Swami |
| Designation |
Professor, Department of Anaesthesia |
| Affiliation |
Bharati hospital and research center, pune |
| Address |
Department of anaesthesia, bharati hospital, bharati vidyapeeth, pune, maharashtra
Bharati hospital, bharati vidyapeeth, pune, maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9822846369 |
| Fax |
|
| Email |
drswamisarita@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Bharati hospital and research centre, dhankwadi, pune |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital, pune |
| Address |
Pune , satara road, Dhankawadi, maharastra |
| 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 Sarita swami |
Bharati hospital and research centre, dhankawadi, pune |
Department of anaesthesia, bharati hospital, bharati vidyapeeth, satara road, Dhankawadi,pune, maharastra, 411043
Pune
MAHARASHTRA |
9822846369
drswamisarita@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Double blind study to assess pre operative nebulization with ketamine vs dexmedetomidine to assess post operative sore throat. |
To assess pre operative nebulization with ketamine vs dexmedetomidine to assess post operative sore throat at 0hr, 4hr, 6hr, 8hr, 12hr, 24 hr. |
| Comparator Agent |
DEXMEDETOMIDINE |
TO ASSESS PRE OPERATIVE NEBULIZATION WITH DEXMEDTOMIDINE TO ASSES POST OPERATIVE SORE THROAT AT 0HR, 4HR, 6HR, 8HR, 12HR, 24HE |
| Comparator Agent |
KETAMINE |
TO ASSESS PRE OPERATIVE NEBULIZATION WITH KETAMINE VS DEXMEDETOMIDINE TO ASSESS POST OPERATIVE SORE THROAT AT 0HR, 4HR, 6HR, 8HR, 12HR, 24HR |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-60 yrs, Either sex, American society of anaesthesiologist ASA I & II, Surgery in supine position under GA lasting for more than 2hrs |
|
| ExclusionCriteria |
| Details |
history of prior sore throat, patient with chronic usage of steroids or NSAIDS, pregnant women, patient requiring more than 2 attempts of intubation, patient on beta blocker, patient having asthma, hypertension etc |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comparative double blind study, preoperative nebulisation with kketamine and dexmeditomidine on the incidence of post operative sore throat. |
Post operative sore throat will be assesed at 0 hr, 4hr, 6hr, 12 hr, 24hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A comparative double blind study, preoperative nebulisation with kketamine and dexmeditomidine on the incidence of post operative sore throat. |
post operative sore throat will be assessed at 0 hr, 4hr,6 hr, 8hr, 12hr, 24 hr over a period of 2 years |
|
|
Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
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)
|
01/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ethical approval will be obtained from ethical committee, once patient enter the pre operative room,the patient will be informed about the the study in a language they fully comprehend , they will be enrolled in study after taking written informed consent , the enrolled study participant will be randomisedinto 2 groups by chit method, A double blind technique will be used, the principal investigator and the patient will be blind about the nebulization and unaware of group allocation, Generl anaesthesia will be administred 15mins after nebulisation, post operative sore throat will monitored at 0,4,6,12,24 hrs. |