| CTRI Number |
CTRI/2023/04/051556 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
04/04/2023 |
| 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
|
Comparing the efficacy of nebulized Dexamethasone vs nebulized Ketamine on post operative sore throat. |
|
Scientific Title of Study
|
Evaluation of efficacy of nebulized Dexamethasone vs nebulized Ketamine on postoperative sore throat in patients undergoing thyroid surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAGHUMANDALA THERISHA |
| Designation |
JUNIOR RESIDENT IN ANAESTHESIOLOY |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE, BLDE UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,SHRI B M PATIL MEDICAL COLLEGE,BANGARAMMA SAJJAN CAMPUS, VIJAYAPURA KARNATAKA,586103
Bijapur
KARNATAKA
586103
India |
| Phone |
8847804456 |
| Fax |
|
| Email |
raghu.therisha01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIJAY V KATTI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE, BLDE UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SHRI B M PATIL MEDICAL COLLEGE, BANGARAMMA SAJJAN CAMPUS, VIJAYAPURA, KARNATAKA,586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9844585900 |
| Fax |
|
| Email |
drvijaykatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAGHUMANDALA THERISHA |
| Designation |
JUNIOR RESIDENT IN ANAESTHESIOLOY |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE, BLDE UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SHRI B M PATIL MEDICAL COLLEGE, BANGARAMMA SAJJAN CAMPUS, VIJAYAPURA, KARNATAKA,586103
Bijapur
KARNATAKA
586103
India |
| Phone |
8847804456 |
| Fax |
|
| Email |
raghu.therisha01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil medical College, BANGARAMMA SAJJAN CAMPUS, VIJAYAPURA, KARNATAKA,586103 |
|
|
Primary Sponsor
|
| Name |
SHRI B M PATIL MEDICAL COLLEGE |
| Address |
BANGARAMMA SAJJAN CAMPUS,BLDE UNIVERSITY, VIJAYAPURA, KARNATAKA,586103. |
| 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 |
| RAGHUMANDALA THERISHA |
SHRI B M PATIL MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY, BANGARAMMA SAJJAN CAMPUS,BLDE UNIVERSITY, VIJAYAPURA, KARNATAKA,586103.
Bijapur
KARNATAKA |
8847804456
raghu.therisha01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI B M PATIL MEDICAL COLLEGE |
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 |
8mg Dexamethasone diluted with 3ml Normal saline will be given as nebulization with 8lits wall mounted oxygen for 15 mins. |
| Intervention |
Ketamine |
50mg Ketamine diluted with 4ml normal saline will be given as nebulization with 8lits of wall mounted oxygen for 15 mins. |
| Comparator Agent |
Normal saline |
15 mins before general anaesthesia , enrolled group C will be given 5ml of Normal saline through nebulization mask with 8 lit wall mounted oxygen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing thyroid surgeries under general anaesthesia with ASA grade 1,2. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
patients with chronic obstructive pulmonary disease.
Allergic history to study drug
Anticipated difficult intubation and mallampati grade more than 2
History of preoperative sore throat
Surgeries lasting beyond 90mins
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of both nebulized Ketamine and nebulized Dexamethasone on post operative sore throat in patients undergoing thyroid surgeries. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of nebulization (Ketamine & Dexamethasone) on hemodynamic parameters. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
14/04/2023 |
| 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="6"
Days="30" |
|
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
|
This study is a comparative, prospective, parallel group double blinded study. this study consists of 3 groups (C,D,K) where K group will receive 5 ml of normal saline as nebulization,D group will receive 8mg of Dexamethasone diluted with 3ml of Normal saline as nebulization and group K will receive 50mg of Ketamine diluted with 4ml of normal saline as nebulization. 90 patients posted for thyroid surgeries under general anaesthesia will be equally divided into 3 groups, 30 each. This study will be conducted in Shri B M Patil medical College, Vijayapura, Karnataka. The primary outcome is to compare the effectiveness of both the nebulized Ketamine & nebulized Dexamethasone on post operative sore throat in patients undergoing thyroid surgeries under general anaesthesia. The secondary outcome is to evaluate the effect of nebulizations on hemodynamic parameters. |