| CTRI Number |
CTRI/2021/08/035855 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF THE EFFECT OF PRE OPERATIVE NEBULISATION OF DRUGS ON POST OPERATIVE SORE THROAT |
|
Scientific Title of Study
|
COMPARISON OF THE EFFECT OF PRE OPERATIVE NEBULISATION OF DEXMEDETOMIDINE AND CLONIDINE ON POST OPERATIVE SORE THROAT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mithra rajasegar |
| Designation |
PG RESIDENT |
| Affiliation |
Sri Manakula Vinayaka Medical College- pondicherry |
| Address |
no 6-first cross carmel convent street
muthialpet-605003
no 55 canteen street
pondicherry-605001
Pondicherry
PONDICHERRY
605003
India |
| Phone |
08903139633 |
| Fax |
|
| Email |
mithrarajasegar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Prabu |
| Designation |
Professor |
| Affiliation |
sri manakula vinayaka medical college- pondicherry |
| Address |
department of anesthesiology
sri manakula vinayagar medical college
madagadipet
kalitheerthalkuppam
no 55 canteen street
pondicherry-605001
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mithra Rajasegar self |
| Designation |
PG resident |
| Affiliation |
Sri Manakula Vinayaka Medical College- pondicherry |
| Address |
no 6-first cross carmel convent street
muthialpet-605003
no 55 canteen street
pondicherry-605001
Pondicherry
PONDICHERRY
605003
India |
| Phone |
08903139633 |
| Fax |
|
| Email |
mithrarajasegar@gmail.com |
|
|
Source of Monetary or Material Support
|
| MITHRA
PG resident
Sri Manakula Vinayagar
Medical College
Madagadipet
no 6 Flos Carmel Convent
layout
mutialpet-605003
phone no:8903139633 |
|
|
Primary Sponsor
|
| Name |
mithrarajasegar |
| Address |
no 6 first cross carmel convent street
mutialpet-605003 |
| 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 |
| mithra |
Sri Manakula Vinayaka medical college |
Department of Anaesthesiology
first floor
Ot complexes 7,8,9
madagadipet
kalitheerthalkuppam-605107
Pondicherry
PONDICHERRY |
8903139633
mithrarajasegar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Manakula Vinayaka Institutional Ethics Commitee |
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 |
Clonidine |
ALPHA 2 AGONIST: DRUG. 50 mcg(1ml) with 1ml normal saline nebulization for 10 minutes and 10 minutes before intubation |
| Intervention |
DEXMEDETOMIDINE |
ALPHA 2 AGONIST: DRUG. 50 mcg(1ml) with 1mlof normal saline nebulization for 10 minutes and 10 minutes before the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
asa physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
PREVIOUS HISTORY OF SORE THROAT FOR PAST ONE WEEK
CHRONIC SMOKER,ASTHMA,CPOD,ORAL INJURIES,HEAD AND NECK INJURIES
DIFFICULT AIRWAY (MP 3 OR 4)
PREGNANT OR LACTATING WOMEN
PATIENT REFUSAL |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INCIDENCE AND SEVERITY OF SORE THROAT |
INCIDENCE AND SEVERITY OF SORE THROAT after surgery for three consecutive days.(post operative day 1,2,3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BLOOD PRESSURE AND HEART RATE
ADVERSE EFFECTS |
ONE YEAR |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/08/2021 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mithrarajasegar@gmail.com].
- For how long will this data be available start date provided 20-06-2023 and end date provided 31-12-2075?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
post operative sore throat occurs in 25 to 65% of patients undergoing general anesthesia with endotracheal intubation with considerable morbidity and discomfort which causes delay in starting oral feeds.it is second most anesthesia related complication.hence we designed this study to compare the effects of pre operative nebulisation of two alpha 2 agonists dexmedetomidine and clonidine which can prevent post operative sore throat with minimal side effects |