| CTRI Number |
CTRI/2021/07/035033 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
20/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of intravenous ondansetron versus lidocaine for pain on propofol injection |
|
Scientific Title of Study
|
To study the effect of 0.1 mg/kg ondanseteron vs 1 mg/kg lidocaine (2%) for amelioration of pain on injection propofol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Bagle |
| Designation |
professor |
| Affiliation |
Dr.D.Y.Patil medical college and research centre |
| Address |
Dr. D. Y. Patil Medical College and research centre, sant tukaram nagar, pimpri, pune
Sant Tukaram nagar, pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bagle |
| Designation |
professor |
| Affiliation |
Dr.D.Y.Patil medical college and research centre |
| Address |
Dr. D. Y. Patil Medical College and research centre, sant tukaram nagar, pimpri, pune
Sant Tukaram nagar
Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Bagle |
| Designation |
professor |
| Affiliation |
Dr.D.Y.Patil medical college and research centre |
| Address |
Dr. D. Y. Patil Medical College and research centre, sant tukaram nagar, pimpri, pune
Sant Tukaram nagar
Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil Medical College and research centre |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Medical College and research centre |
| Address |
Sant tukaram nagar ,Pimpri ,Pune |
| 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 |
| Dr Krusha Shah |
Department of anesthesiology,Dr. D. Y. Patil Medical College and research centre |
sant tukaram nagar, pimpri
Pune
MAHARASHTRA |
9422710943
shahkrusha07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Injection 1mg/kg lidocaine(2%) |
Injection 1mg/kg lidocaine (2%) iv prior to injection propofol |
| Intervention |
Injection ondansetron 0.1mg/kg |
Injection ondansetron 0.1mg/kg iv prior to injection propofol |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1 and 2 fit patients
Patients who give oral and written consent |
|
| ExclusionCriteria |
| Details |
Patients allergic to this drug
Patients with respiratory, neurological, cardiovascular and renal disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of efficacy of intravenous 0.1mg/kg ondansetron versus 1mg/kg
lidocaine (2%) for amelioration of pain on injection of propofol
Pain will be assessed using VAS Score and withdrawal scale |
Comparison of efficacy of intravenous 0.1mg/kg ondansetron versus 1mg/kg lidocaine (2%) for amelioration of pain on injection of propofol
Pain will be assessed at the time of injecting 20 cc iv injection propofol |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
30/07/2021 |
| 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="0"
Months="6"
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 - 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 - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shahkrusha07@gmail.com].
- For how long will this data be available start date provided 01-02-2022 and end date provided 28-02-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
comparison of efficacy of intravenous injection ondansetron versus lidocaine for pain on propofol injection |