| CTRI Number |
CTRI/2025/02/079971 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two drugs to be given before Spinal Anaesthesia to avoid post operative Nausea and Vomiting. |
|
Scientific Title of Study
|
A Comparative study of efficacy of Prophylactic Ondansetron Versus Dexamethasone In Prevention Post Operative Nausea and Vomiting In Patients Receiving Intrathecal Opioids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreyash Gosavi |
| Designation |
Junior Resident -2 |
| Affiliation |
Grant Government Medical College and JJ Hospital , Mumbai |
| Address |
Department of Anaesthesia,Main building 6th floor, GGMC, mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8879870353 |
| Fax |
|
| Email |
gosavishreyash41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kundan Gosavi |
| Designation |
Professor |
| Affiliation |
Grant Government Medical College JJ Hospital |
| Address |
Department of Anaesthesia, Grant Government Medical College, JJ Hospital Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9221461101 |
| Fax |
|
| Email |
kundangiri@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kundan Gosavi |
| Designation |
Professor |
| Affiliation |
Grant Government Medical College JJ Hospital |
| Address |
Department of Anaesthesia, Grant Government Medical College, JJ Hospital Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9221461101 |
| Fax |
|
| Email |
kundangiri@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Grant Government Medical College JJ Hospital Mumbai, 400008, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Shreyash Gosavi |
| Address |
Department of Anaesthesia Grant Government Medical College JJ Hospital Mumbai 400008 , Maharashtra, India |
| Type of Sponsor |
Other [Nil] |
|
|
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 Shreyash Gosavi |
Grant Government Medical College JJ Hospital |
Department of Anaesthesia, GGMC , Main hospital building 6th floor, byculla Mumbai 400008
Mumbai
MAHARASHTRA |
8879870353
gosavishreyash41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Grant Government Medical College JJ Hospital , IEC PG 140 APR 2024 |
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 intravenous 4 mg |
Dexamethasone is a synthetic glucocorticoid intravenous 4 mg given 10 minutes before Spinal Anaesthesia, Duration of action 8-10 hrs |
| Intervention |
Ondansetron 4 mg intravenous |
Ondansetron 4 mg is Serotonin 5- HT3 Receptor antagonist given 10 minutes before Spinal Anaesthesia, Duration of action 8-10 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1&2, Posted for lower abdomen urology lower limb surgeries under Spinal Anaesthesia using Opioid as additive |
|
| ExclusionCriteria |
| Details |
Patient not giving consent, having cardiovascular and renal diseases, patient allergic to any of study drugs , patient requiring General anaesthesia, expected of having major blood los |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in occurence of post operative Nausea and Vomiting after using prophylactic ondansetron or dexamethasone in patients receiving intrathecal Opioids |
Changes in occurence of post operative Nausea and Vomiting in Post operative period at 60 min, 120 min, 180 min, 240 min, 300 min, 360 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study various rescue medication required to treat post operative Nausea Vomiting in patients receiving intrathecal Opioids |
Rescue medication required for post operative Nausea Vomiting after 60 minutes post operative, 120 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
12/02/2025 |
| 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="10"
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 comparative study of two drugs which are used for prevention of post operative Nausea and Vomiting in patients receiving intrathecal Opioids, as Opioids leads to more chances of nausea and Vomiting. Rescue medications requiring will also be analysed. Assessment will be done in intraoperative period but majorly in post operative period. Data will be collected and analysed |