| CTRI Number |
CTRI/2024/11/077170 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
we will be Comparing the efficacy of two drugs in abdominal surgery patients for post operative nausea and vomiting and their outcome |
|
Scientific Title of Study
|
Comparison of Amisulpride vs Ondansetron in the prophylaxis of Post Operative Nausea and Vomiting in abdominal surgeries: a randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Sinha |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department Of Anesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8709607612 |
| Fax |
|
| Email |
Hsinha111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeev Kumar Dubey |
| Designation |
Proffesor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department Of Anesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839927283 |
| Fax |
|
| Email |
rajeevdubeyrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeev Kumar Dubey |
| Designation |
Proffesor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department Of Anesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839927283 |
| Fax |
|
| Email |
rajeevdubeyrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesiology
Institute of Medical Sciences
Banaras Hindu University
Lanka, Varanasi 221005
India
|
|
|
Primary Sponsor
|
| Name |
Department Of Anesthesiology Institute of Medical Sciences Banaras Hindu University |
| Address |
Department Of Anesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221005.
India
|
| 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 |
| HARSHITA SINHA |
SIR SUNDER LAL HOSPITAL |
DEPARTMENT OF ANESTHESIOLOGY
INSTITUE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH |
8709607612
HSSINHA111@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Banaras Hindu University Institute of Medical Sciences Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
amisulpride |
5 mg diluted in 5 ml ns intravenously before extubation and followed at 0 6 and 24 hours |
| Comparator Agent |
ondansetron |
4mg iv diluted in 5 ml intravenously given before extubation and followed up at 0 6 and 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I or II physical status
3. patient’s consent
4.Patients with three or more risk factors for nausea and vomiting
|
|
| ExclusionCriteria |
| Details |
Pregnancy
lactation
renal impairment
History of allergic reaction to the drugs mentioned in study.
Refusal to take part in the study.
Patients with dysrhythmia
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. association of redcution in PONV With amisulpride in comparison to ondansetron |
1.KOIVURANTA SCALE
2. APFEL SCORE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.to asses post op nausea vomiting at |
1. 2hrs,6hrs,24hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
11/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Presently dopamine (D2), serotonin (5-HT3), and histamine (H1) antagonists are widely used prophylactic agents, as is the corticosteroid dexamethasone, but the incidence of postoperative nausea and vomiting (PONV) is still appreciable. Safety concerns as QT interval prolongation has led to nearly phasing out of use of D2-antagonist Droperidol, a potent and most favoured formulation. With minimal studies and randomized studies to back up the efficacy of existing modalities viz 5HT-antagonist, promethazine, metoclopramide and dimenhydrinate for management of postoperative nausea and vomiting, need for evaluation, study and incorporation into formulary for management was always persisting.[ 3] Amisulpride is an anti-psychotic agent, used routinely are a potent but atypical D2-antagonist with minimal adverse profile mainly QT interval prolongation, as compared to ondansetron extrapyramidal signs and symptoms, which had plagued out other members of same class. In addition to D2 antagonism this drug exhibits potent antagonist action against D3 receptors, implicated in the emetic response. In pre-clinical studies and multiple randomized controlled multicentre studies, the effectiveness and safety of low dose intra venous the purpose of this study is To study effects on post operative nausea and vomiting in patients receiving amisulpride 5mg and compare it with patients receiving 4mg of ondansetron using apfel score and koivuranta nausea and vomiting total score |