| CTRI Number |
CTRI/2020/08/027327 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
19/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of giving ketamine nebulization before surgery to reduce occurance of throat pain due to tracheal intubation after surgery |
|
Scientific Title of Study
|
Evaluation of efficacy of ketamine nebulization on reduction of incidence and severity of postoperative sore throat due to tracheal intubation-A randomized controlled study. |
| Trial Acronym |
ketamine, sore throat |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Heli Mehta |
| Designation |
PG Student |
| Affiliation |
SSG Hospital,Vadodara. |
| Address |
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,Vadodara
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9662530645 |
| Fax |
|
| Email |
helimehta94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Brahmbhatt |
| Designation |
Associate Professor |
| Affiliation |
SSG Hospital,Vadodara. |
| Address |
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,Vadodara
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9428764477 |
| Fax |
|
| Email |
nimishabrahmbhatt7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heli Mehta |
| Designation |
PG Student |
| Affiliation |
SSG Hospital,Vadodara. |
| Address |
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,Vadodara
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,Vadodara
Vadodara
GUJARAT
391345
India |
| Phone |
9662530645 |
| Fax |
|
| Email |
helimehta94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SSG HospitalVadodara |
| Address |
SSG Hospital,
Near Kalaghoda Circle,
Sayajigunj,Vadodara |
| Type of Sponsor |
Government 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 Heli Mehta |
SSG Hospital |
2nd Floor,
Dept.Of Anesthesia,
New surgical block,
SSG Hospital,
Vadodara-390001
Vadodara
GUJARAT |
9662530645
helimehta94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR-PGR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine nebulization |
preoperatively 15 mins before induction, 50 mg ketamine(1cc)diluted with normal saline to 5 cc given through nebulization mask for 10 mins. |
| Comparator Agent |
normal saline nebulization |
preoperatively 15 mins before induction, 5 cc normal saline given through nebulization mask for 10 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients posted for elective surgery under general anesthesia requiring endotracheal intubation in supine position with surgery duration of 1-3 hours.
2) Age: 18-60 years
3) Gender: Either gender.
4) ASA I & II
|
|
| ExclusionCriteria |
| Details |
1-Patient’s refusal.
2-History of prior sore throat
3-Patients using steroids or NSAIDS
4-Patients with COPD, asthma
5-Patient with difficult airway.
6-Known allergy to study drug.
7-Surgery involving oral cavity, nasopharynx, neck region and surgeries with throat pack.
8-Pregnant patients.
9-Patients with >1 attempt of intubation
10-Presence of excessive bucking at time of extubation.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of nebulized ketamine in reducing incidence and severity post-operative sore throat in adult patients undergoing general anesthesia |
The incidence and severity of sore throat will be recorded at 2,4,6, 12 and 24 hours post operatively, measured on 4 points scale 0-3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-to observe for side effects like cough,nausea,vomiting,hallucination
2-to observe relation between gender and duration of surgery to incidence of post operative sore throat
3- to compare hemodynamics between both groups |
pre nebulisation,5 mins post nebulisation,at time of induction,10 mins post-induction,post-extubation.
and 0,2,4,6,12,24 hourly |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2020 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Our purpose of this study is to evaluate efficacy of ketamine nebulization in reducing incidence and intensity of post operative sore throat in patients receiving general anesthesia with endotracheal intubation. |