| CTRI Number |
CTRI/2024/10/074593 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized controlled trial to study the effect of nebulization with ketamine versus normal saline on postop sore throat in patient after intubation. |
|
Scientific Title of Study
|
A randomized controlled trial to study the effect of preoperative nebulization with Ketamine versus normal saline on post-operative sore throat in patient after endotracheal intubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Kumar |
| Designation |
Pg resident |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
OP Jindal hostel
Maharaja Agrasen Medical College
Agroha,Hisar
Hisar
HARYANA
125047
India |
| Phone |
08708719005 |
| Fax |
|
| Email |
akshaykumar.ynr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibha Mehta |
| Designation |
Proffessor |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Department of Anaesthesia,
Maharaja Agrasen Medical College,Agroha
Agroha,Hisar
Hisar
HARYANA
125047
India |
| Phone |
9466088221 |
| Fax |
|
| Email |
drvibhamehta1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibha Mehta |
| Designation |
Proffessor |
| Affiliation |
Maharaja Agrasen Medical College |
| Address |
Department of Anaesthesia,
Maharaja Agrasen Medical College,Agroha
Agroha,Hisar
Hisar
HARYANA
125047
India |
| Phone |
9466088221 |
| Fax |
|
| Email |
drvibhamehta1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Agroha Hisar haryana 125047 india |
|
|
Primary Sponsor
|
| Name |
Akshay kumar |
| Address |
Room no 201 OP Jindal hostel
Agroha Hisar Haryana 125047 India |
| 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 Akshay Kumar |
Maharaja Agrasen Medical College |
Department of Anaesthesia Agroha Hisar
Hisar
HARYANA |
8708719005
akshaykumar.ynr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee for human research |
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 |
Nebulization with Ketamine |
1 ml diluted with 4 ml distilled water for 2 minutes one year four month |
| Comparator Agent |
Nebulization with Normal Saline |
5 ml normal saline for 2 minutes
one year four month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18–60 years of either sex.
2. American Society of Anesthesiologists (ASA) physical status class I and II.
3. Duration of surgery 2-3 hours.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. History of preoperative sore throat 1 week prior to surgery
3. Oral / Head and neck surgeries
4. Asthma/ Chronic obstructive pulmonary disease
5. Morbid obesity
6. Difficult intubation (mallampati grade more than 2)
7. Patient requiring nasogastric tube
8. Allergies to study drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence and severity of postoperative sore throat using POST score at 2hour,4hour,6hour and 12 hours
after extubation in both the groups. |
Incidence and severity of postoperative sore throat using POST score at 2hour,4hour,6hour and 12 hours
after extubation in both the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of preoperative nebulization with Ketamine and normal saline on hemodynamics (HR,BP) |
After 5 minutes of nebulization,vitals will be checked |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="1"
Months="4"
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
|
I will take patient between 18-60 years of age group undergoing tracheal intubation. patient will be nebulized preoperatively with ketamine and normal saline to see their effect on post operative sore throat after intubation. |