| CTRI Number |
CTRI/2024/11/077240 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effects of ondansetron and ondansetron with dexamethasone in reducing postoperative nausea and vomiting in elective surgeries under general anaesthesia |
|
Scientific Title of Study
|
Comparison of the efficacy of ondansetron alone versus ondansetron and dexamethasone in the prevention or reduction of post operative nausea and vomiting after elective surgeries under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Juhi Mishra |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia Varun arjun medical college and rohilkhand hospital lucknow road banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7985284698 |
| Fax |
|
| Email |
juhimishra.9x@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Nath Shukla |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7080470075 |
| Fax |
|
| Email |
richanshu45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyen Verma |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7007564027 |
| Fax |
|
| Email |
Vermasatyen1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital Lucknow road Banthara district Shahjahanpur Uttar Pradesh India 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Juhi Mishra |
| Address |
room no.1004 department of anaesthesia first floor Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthara Shahjahanpur Uttar Pradesh India Pin code 242307 |
| 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 |
| Dr Juhi Mishra |
Rohilkhand Hospital Banthara, Shahjahanpur |
Department of Anaesthesia Varun Arjun Medical College, Banthara. District- Shahjahanpur, Uttar Pradesh, India Shahjahanpur
UTTAR PRADESH
Shahjahanpur
UTTAR PRADESH |
7985284698
juhimishra.9x@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Varun Arjun Medical College & Rohilkhand Hospital NH24 Banthara shahjahanpur Uttar Pradesh 242307 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combination of ondansetron 4mg and dexamethasone 8mg |
Patients under going elective surgeries under general anaesthesia will receive iv combination of ondansetron 4mg and dexamethasone 8mg in 1 year |
| Intervention |
Ondansetron 4mg |
Patients undergoing elective surgeries under general anaesthesia will receive intravenous ondansetron 4mg in 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Able to provide informed consent
2.American Society of Anaesthesiologists (ASA) physical status I and II |
|
| ExclusionCriteria |
| Details |
Patients with contraindications to either medication
Patients requiring emergency surgery or those undergoing surgeries with known high PONV
risk
Severe cardiorespiratory hepatic renal neurological or endocrinal disease obesity diabetes
mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative analgesic effects between ondansetron and ondansetron with dexamethasone |
2hours 6hours 12hours 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify any potential predictors of optimal dose selection and see the efficacy of both drugs in full 24 hours |
2hours 6hours 12hours 24hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is designed to provide evidence that may guide clinical decision-making in managing PONV, potentially improving patient comfort and recovery outcomes. If the combination therapy proves to be more effective than ondansetron alone, it could become the preferred treatment option for preventing PONV in this patient population. Conversely, if both regimens show similar efficacy, the simpler treatment of ondansetron alone may be sufficient, with implications for reducing treatment costs and minimizing medication-related side effects. This study seeks to add valuable insights into the optimal management strategies for PONV, contributing to enhanced patient care following elective surgeries |