| CTRI Number |
CTRI/2026/01/100121 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two doses of Amisulpride for prevention of postoperative nausea and vomiting in cardiac surgery patients |
|
Scientific Title of Study
|
Antiemetic efficacy of prophylactic amisulpride 5 mg versus amisulpride 10 mg in patients undergoing cardiac surgery under cardiopulmonary bypass machine: A randomized double-blinded, controlled trial |
| 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 Sanjeev Kumar |
| Designation |
Associate Professor |
| Affiliation |
IMS BHU |
| Address |
Associate Professor, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09650063508 |
| Fax |
|
| Email |
dr.sanjeevkumarkem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Associate Professor |
| Affiliation |
IMS BHU |
| Address |
Associate Professor, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
09650063508 |
| Fax |
|
| Email |
dr.sanjeevkumarkem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Associate Professor |
| Affiliation |
IMS BHU |
| Address |
Associate Professor, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
09650063508 |
| Fax |
|
| Email |
dr.sanjeevkumarkem@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir Sunderlal Hospital, IMS, BHU |
| Address |
IMS, BHU, Varanasi, Pin-221005 |
| 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 Sanjeev Kumar |
Sir Sunderlal Hospital, Institute of Medical Sciences |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
09650063508
dr.sanjeevkumarkem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amisulpiride 10 mg intravenously (total volume 2 ml) |
All patients will be shifted to CTVS ICU and put on elective ventilation, Amisulpiride 10 mg given intravenously 30 minutes before plannned for tracheal extubation and follow up for postoperative nausea and vomiting for 48 hours |
| Intervention |
Amisulpiride 5 mg given intravenously (total volume 2 ml) |
All patients will be shifted to CTVS ICU and put on elective ventilation, Amisulpiride 5 mg given intravenously 30 minutes before plannned for tracheal extubation and follow up for postoperative nausea and vomiting for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA PS II and III
2) scheduled to undergo elective valvular heart repair under cardiopulmonary bypass machine |
|
| ExclusionCriteria |
| Details |
1) Known allergy/hypersensitivity to the drug used in the study
2) patients with ventricular arrhythmias
3) patients with preoperative cardiopulmonary resuscitation
4) preoperative mechanical ventilation or dialysis
5) patients who underwent surgical reexploration |
|
|
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 |
| Comparison of antiemetic efficacy of amisulpride 5 mg with that of amisulpride 10 mg in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing cardiac surgery under cardio-pulmonary bypass machine |
Symptoms of PONV at 0 (time of tracheal extubation),6,12,18,24,30,36,42,48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) requirement of rescue antiemetic
2) effect of amisulpride on QT interval
3) any other adverse event due to amisulpride |
Symptoms of PONV at 0 (time of tracheal extubation),6,12,18,24,30,36,42,48 hours |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aim: Comparison of antiemetic efficacy of amisulpride 5 mg with that of amisulpride 10 mg in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing cardiac surgery under cardio-pulmonary bypass machine Methods: Study will be conducted after Ethics committee approval in adult patients of either sex belonging to ASA PS II and III class undergoing cardiac surgery under cardio-pulmonary bypass machine. Patients (total 140) will be randomly assigned into two groups: Group A: receiving amisulpride 5 mg intravenously; Group B: receiving amisulpride 10 mg intravenously Objectives: Primary- Antiemetic efficacy of amisulpride 5 mg versus amisulpride 10 mg Secondary- 1) requirement of rescue antiemetic (dexamethasone 8 mg) 2) effect of amisulpride on QT interval
3) any other adverse event due to amisulpride
Study period : 1 year |