| CTRI Number |
CTRI/2020/07/026342 [Registered on: 03/07/2020] Trial Registered Prospectively |
| Last Modified On: |
26/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
dexamethasone and ketamine nebulisation beforesurgery relive the sorethroat after surgery
|
|
Scientific Title of Study
|
Comparison of efficacy of preoperative nebulisation of ketamine and dexamethasone in attenuating the incidence and severity of post operative sore throat :a randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya R Thota |
| Designation |
Resident doctor |
| Affiliation |
B.J. Medical college and civil hospital |
| Address |
Department oF Anaesthesiology ,F-3 Wing BJMC and civil hospital , Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9607724054 |
| Fax |
|
| Email |
navya.r.thota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran B Patel |
| Designation |
Assistant Professor |
| Affiliation |
B.J. Medical college and civil hospital |
| Address |
Department oF Anaesthesiology ,F-3 Wing BJMC and civil hospital , Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran B Patel |
| Designation |
Assistant Professor |
| Affiliation |
B.J. Medical college and civil hospital |
| Address |
Department oF Anaesthesiology ,F-3 Wing BJMC and civil hospital , Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BJ Medical college and civil hospital , asarwa Ahmedabad , Gujarat 380016
|
|
|
Primary Sponsor
|
| Name |
BJ medical college and civil hospital |
| Address |
BJMC and civil hospital , asarwa , ahmedabad gujarat |
| 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 Navya R Thota |
BJ Medical college and civil hospital ,Ahmedabad |
f_3 wing general surgery department ,BJ medical college and civil hospital ,Ahmedabad
Ahmadabad
GUJARAT |
9607724054
navya.r.thota@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Commitee , BJ Medical college & Civil Hospital , Ahmedabad |
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 |
| Comparator Agent |
Dexamethasone |
assessing the efficacy of preoperative nebulisation of dexamethasone 8mg( 2ml) in 3 ml normal saline in reducing the post operative sore throat for 24 hours and noting side effects if any |
| Comparator Agent |
Ketamine |
to asses efficacy of preoperative nebulisation of ketamine 50 mg in 4ml normal saline in reducing post operative sore throat for 24 hours post operative period and noting side effects if any |
| Intervention |
Nebulisation |
comparing the efficacy of reducing post operative sore throat by giving preoperative nebulisation with ketamine 50 mg with 4 ml normal saline and that with dexamethasone 8 mg with 3 ml normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1 and 2
Elective surgeries under general anaesthesia
Endotracheal intubation under general anaesthesia
Supine position |
|
| ExclusionCriteria |
| Details |
Preoperative sore throat , upper respiratory tract infection , chronic obstructive pulmonary disease, bronchial asthama
Mallampatti grade >2
Patients undergoing oral surgeries , head and neck surgeries
Allergy to any one or both studying drugs
Pregnancy and lactating mother
Current use of cortico steroids
Immuno compromised patients /long term use of immunosuppressants
patients with risk factors for post operative aspiration
>1 attempt of intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of efficacy of attenuating severity and incidence of postoperative sorethroat due to preoperative nebulisation . |
Duration of reduction in post operative sore throat due to preoperative nebulisation upto 24 hours post operative period . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of either of the drugs in reducing post operative sorethroat and side effects if any. |
24 hour post operative period . |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2020 |
| Date of Study Completion (India) |
20/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective randomized study to compare the effictiveness of preoperative nebulisation of ketamine and dexamethasone to attenuate severity and incidence post operative sore throat in patients undergoing surgery under general anaesthesia . Patients will be followed up for post operative sore throat and graded accordingly for a period of 24 hours post operatively . there are two groups Group K - patients receiving preoperative nebulisation with ketamine 1ml(50 mg) with 4 ml normal saline Group D - patients receiving preoperative nebulisation with dexamethasone 8mg (2ml ) with 3 ml normal saline the hypothesis of this study is that preoperative nebulisation of these drugs reduces the incidence and severity of post operative sore throat |