| CTRI Number |
CTRI/2024/06/069060 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Ketamine Gargle and KY Jelly for prevention of sore throat in procedures done under general anaesthesia |
|
Scientific Title of Study
|
Comparison of Ketamine Gargle and KY Jelly for prophylaxis of post operative sore throat in 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 Sanjot Ninave |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of higher education and research Centre |
| Address |
Department of Anaesthesia
AVBRH Sawangi Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9921213404 |
| Fax |
|
| Email |
drsusann02@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angan Ghosh |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of higher education and research Centre |
| Address |
Department of Anaesthesia
AVBRH Sawangi Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
8826897423 |
| Fax |
|
| Email |
angan.ghosh05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjot Ninave |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of higher education and research Centre |
| Address |
Department of Anaesthesia
AVBRH Sawangi Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9921213404 |
| Fax |
|
| Email |
drsusann02@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher education and research Centre , Sawangi , Wardha-442004 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher education and research Centre |
| Address |
Datta Meghe Institute of higher education and research Centre, Sawangi,Wardha,Maharashtra,442004 |
| 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 Sanjot Ninave |
Acharya Vinoba Bhave rural Hospital |
Department of Anaesthesia.
Wardha
MAHARASHTRA |
9921213404
drsusann02@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post operative sore throat prophylaxis using Ketamine Gargle. Duration-24 hours. |
50 mg Injection Ketamine in 29 ml Normal Saline (Total Volume-30 ml) via Gargle 5 minutes before induction.Duration-24 hours. |
| Comparator Agent |
Post operative sore throat prophylaxis using KY Jelly |
1 ml KY Jelly via gel application to endotracheal tube during induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing to participate in the study.
2)Patients in age group of 18-65 years.
3)Patient fulfilling criteria for intubation under General Anesthesia.
4)Patient undergoing surgical procedures under General Anaesthesia.
5)Duration of Surgery 2-3 hours .
6)ASA I & 2
7)MPC I & II .
|
|
| ExclusionCriteria |
| Details |
1)Lack of valid informed written consent .
2)ASA grade 3 & 4 .
3)Patients with history of prior or recent sore throat, patients with known upper respiratory tract infection or lower respiratory tract infection.
4)Patients with known allergy, sensitivity or any other form of reaction to study drug.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the use of Ketamine Gargle and KY Jelly in reducing the post operative sore throat following General Anaesthesia. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Number of patients complaining of post operative sore throat
2) Correlation of duration of intubation with the occurrence of postoperative throat pain.
3) Any side effects.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2024 |
| 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 Yet Recruiting |
| 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
|
Purpose of the trial is to compare the efficacy of Ketamine Gargle over KY Jelly for prophylaxis of postoperative sore throat in General Anaesthesia.
To see whether the patient is having less postoperative sore throat ,coughing and hoarseness of voice when Ketamine Gargle is used 5 minutes before induction over application of KY Jelly to endotracheal tube during induction
|