| CTRI Number |
CTRI/2019/09/021417 [Registered on: 25/09/2019] Trial Registered Prospectively |
| Last Modified On: |
24/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare palonosetron and ondansetron in preventing postoperative nausea and vomiting in patients undergoing renal transplant. |
|
Scientific Title of Study
|
To compare the effect of palonosetron and ondansetron in preventing post operative nausea vomiting in patient undergoing living donor renal transplantation : a randomized double blind observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep sahu |
| Designation |
Additional professor |
| Affiliation |
Sanjay Gandhi post graduate institute of medical sciences |
| Address |
Department of anesthesiology
Sanjay Gandhi post graduate institute of medical sciences, lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904598 |
| Fax |
|
| Email |
drsandeepsahu@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanvi bhargava |
| Designation |
Senior resident |
| Affiliation |
Sanjay Gandhi post graduate institute of medical sciences |
| Address |
Department of anesthesiology
Sanjay Gandhi post graduate institute of medical sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
07080995711 |
| Fax |
|
| Email |
tanvib06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanvi bhargava |
| Designation |
Senior resident |
| Affiliation |
Sanjay Gandhi post graduate institute of medical sciences |
| Address |
Department of anesthesiology
Sanjay Gandhi post graduate institute of medical sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
07080995711 |
| Fax |
|
| Email |
tanvib06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi post graduate institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sandeep sahu |
Sanjay gandhi post graduate institute of medical scienes |
Department of anesthesiology
A block, 1st floor
Sanjay gandhi post graduate institute of medical scienes, lucknow
Uttar pradesh
Lucknow
UTTAR PRADESH |
8004904598
drsandeepsahu@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee Sanjay Gandhi post graduate institute of medical sciiences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ondensetron |
5-HT3 antagonist used to prevent postoperative nausea and vomiting with half life of 6hrs |
| Comparator Agent |
Palonosetron |
5-HT3 receptor antagonist used to prevent postoperative nausea and vomiting with a longer half life of 40-50 hrs . Prevents both early and late onset post operative nausea vomiting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Renal transplant recipients |
|
| ExclusionCriteria |
| Details |
History of motion sickness
History of chronic anti emetic medications
Known smokers
History of allergy to ondensetron and polonosetron |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of polonosetron and ondensteronin preventing post operative nausea and vomiting using PONV score wengritzky Rt.al |
To compare the effects of polonosetron and ondensteronin preventing post operative nausea and vomiting using PONV score wengritzky Rt.al at 0,1hr, 6hr, 12hr,24hr and 72 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
30/09/2019 |
| 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
|
No published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Post operative nausea and vomiting is a common complaint in the post operative period , in patients with end stage renal disease they have delayed gastric emptying due to urenmic Gastro patchy and concomitant diabetes increases changes of nausea and vomiting in post operative period. Ondensetron is a short acting antiemetic , which has limited duration of action. Palonosetron is a long acting antiemetic which not only decreases early onset PONV but also decreases nausea and vomiting 48-72 hrs after transplantation. We aim to compare the efficacy of these two agents by using the PONV intensity score. |