| CTRI Number |
CTRI/2022/08/044664 [Registered on: 05/08/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Dexamethasone, Normal saline and Ketamine in prevention of post-operative sore throat. |
|
Scientific Title of Study
|
Comparison of the effect of intracuff Normal saline, Dexamethasone or ketamine for prevention of post-operative sore throat: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyabrat Karan |
| Designation |
Senior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anesthesiology and critical care.
Aiims jodhpur , rajasthan
pin 342008
Department of anesthesiology and critical care
Aiims jodhpur
Jodhpur
RAJASTHAN
342008
India |
| Phone |
8260255556 |
| Fax |
|
| Email |
karanpriyabrat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anesthesiology and critical care .
Aiims jodhpur, rajasthan
Department of anesthesiology and critical care
Aiims jodhpur, rajasthan
Jodhpur
RAJASTHAN
342008
India |
| Phone |
8279265105 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyabrat Karan |
| Designation |
Senior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of anesthesiology and critical care.
Aiims jodhpur, rajasthan
Department of anesthesiology and critical care.
Aiims jodhpur, rajasthan
Jodhpur
RAJASTHAN
342008
India |
| Phone |
8260255556 |
| Fax |
|
| Email |
karanpriyabrat@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priyabrat Karan |
| Address |
Department of anesthesiology and critical care AIIMS jodhpur, Rajasthan
pin 342008 |
| 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 |
| Priyabrat Karan |
AIIMS JODHPUR |
Department of anesthesiology and critical care, Aiims jodhpur
Jodhpur
RAJASTHAN |
8260255556
karanpriyabrat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Clinical Trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone 0.2 mg/kg intra cuff in endotracheal tube |
Use of Dexamethasone in preventing sore throat |
| Comparator Agent |
Ketamine 20 mg intracuff in endotracheal tube |
Use of Ketamine in preventing sore throat |
| Comparator Agent |
NORMAL SALINE 3ml intracuff in endotracheal tube |
To compare dexamethasone , ketamine and normal saline in prevention of sore throat. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients between age group 18 to 60 years without any allergic history |
|
| ExclusionCriteria |
| Details |
Patients refusing for trial and patients having allergy to drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of post-operative Sore throat |
Incidence and severity of post-operative Sore throat at 2, 6, 12 & 24 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of post-operative hoarseness of voice and post-operative cough |
2, 6, 12 & 24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="405"
Sample Size from India="405"
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)
|
01/09/2022 |
| 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="2"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients undergoing surgery under general anesthesia requiring endotracheal intubation often complain of post-operative sore throat. We are comparing two drugs in this trial to prevent post-operative sore throat in patients undergoing surgery. Prevention of post-operative sore throat helps in patient satisfaction after surgeries . |