| CTRI Number |
CTRI/2024/09/074272 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on evaluation of efficacy of Ondansetron and Palonosetron for prevention of post operative nausea and vomiting. |
|
Scientific Title of Study
|
Comparative Study of the Efficacy of Intravenous Ondansetron Versus Intravenous Palonosetron in the Prevention of Postoperative Nausea and Vomiting in Elective Laparoscopic Surgeries |
| 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 Sumangala Mulagund |
| Designation |
postgraduate student |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Department of Anesthesiology is located on the 4th floor of the Gulbarga Institute of Medical Sciences, along Sedam Road in Kalaburagi.
Gulbarga
KARNATAKA
585105
India |
| Phone |
7899235963 |
| Fax |
|
| Email |
sumangala886@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusha Dhage |
| Designation |
Associate professor |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Department of Anesthesiology, 4th Floor Gulbarga Institute of Medical Sciences Sedam Road Kalaburagi.
Gulbarga
KARNATAKA
585105
India |
| Phone |
9538404005 |
| Fax |
|
| Email |
anudha.dhage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Dhage |
| Designation |
Associate professor |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Department of Anesthesiology, Gulbarga Institute of Medical Sciences, Kalaburagi.
Gulbarga
KARNATAKA
585105
India |
| Phone |
9538404005 |
| Fax |
|
| Email |
anudha.dhage@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gulbarga institute of medical sciences Kalaburagi 585105 |
|
|
Primary Sponsor
|
| Name |
Gulbarga institute of medical sciences |
| Address |
Gulbarga institute of medical sciences Veeresh Nagar Sedam road Kalaburagi 585105 |
| Type of Sponsor |
Government 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 Sumangala Mulagund |
Surgery operation theatre Department of anesthesiology Gulbarga institute of medical sciences |
Department of anesthesiology Gulbarga institute of medical sciences Kalaburagi 585105
Gulbarga
KARNATAKA |
7899235963
sumangala886@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GULBARGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ondansetron |
to study efficacy of intravenous Ondansetron 4mg in prevention of nausea and vomiting for 0-2hours, 2-6hours, 6-24 hours postoperatively |
| Comparator Agent |
Palonosetron |
to study efficacy of intravenous Palonosetron 75mcg in prevention of nausea and vomiting compared to ondansetron 0-2hours, 2-6hours, 6-24 hours postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) grade I and II
Patients giving informed written valid consent.
Either sex.
Patients scheduled to undergo elective laparoscopic surgeries. |
|
| ExclusionCriteria |
| Details |
History of allergy to Ondansetron or Palonosetron.
Patients posted for emergency surgery.
Pregnant
History of nausea and vomiting 24hrs prior to surgery.
History of motion sickness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of ondansetron and palonosetron in reducing the incidence of postoperative nausea and vomiting. |
To compare the efficacy of ondansetron and palonosetron on the incidence of postoperative nausea and vomiting, the postoperative periods of 0-2 hours, 2-6 hours, and 6-24 hours should be considered. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine hemodynamic parameters & adverse effects in both groups. |
0-2 hours, 2-6hours, 6-24hours postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/12/2024 |
| 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="6"
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
|
This study is mainly aiming to study the efficacy of two different drugs. Here ondansetron is already an established drug where palonosetron in newly introduced in use for postoperative nausea and vomiting in all laparoscopic surgeries. Hope this study is helpful in knowing efficacy of palonosetron. |