| CTRI Number |
CTRI/2025/09/095445 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare Amisulpride and Ondansetron for Postoperative Nausea and Vomiting prophylaxis in patients undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Amisulpride over Ondansetron for Postoperative Nausea and Vomiting prophylaxis: A double blind Randomized control 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 |
AMAN MATHUR |
| Designation |
Post graduate student, DNB |
| Affiliation |
Central Hospital NFR |
| Address |
Room 1 ground floor postgraduate hostel Central Hospital NFR PNGB road Maligaon Guwahati Assam
781011
India
Kamrup ASSAM 781011 India |
| Phone |
9413370058 |
| Fax |
|
| Email |
amanmathur237@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Paramanand Maheshwari |
| Designation |
Chief Consultant (H) |
| Affiliation |
N F Railway Central Hospital |
| Address |
Department of Anesthesiology
N F Railway Central Hospital
Maligaon, Guwahati
Assam 781011
India
Kamrup ASSAM 781011 India |
| Phone |
9435150509 |
| Fax |
|
| Email |
drpmaheshwari@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Paramanand Maheshwari |
| Designation |
Chief Consultant (H) |
| Affiliation |
N F Railway Central Hospital |
| Address |
Department of Anesthesiology
N F Railway Central Hospital
Maligaon, Guwahati
Assam 781011
India
Kamrup ASSAM 781011 India |
| Phone |
9435150509 |
| Fax |
|
| Email |
drpmaheshwari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Hospital NF railway, Maligaon Guwahati Assam 781011 India |
|
|
Primary Sponsor
|
| Name |
Dr Aman Mathur |
| Address |
Central Hospital NFR PNGB road Maligaon Guwahati Assam 781011 |
| Type of Sponsor |
Other [Dr Aman Mathur] |
|
|
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 Aman Mathur |
Department of Anesthesiology and Critical Care Central Hospital NF railway |
Central Hospital NFR PNGB road Maligaon Guwahati Assam 781011 India Kamrup ASSAM |
9413370058
amanmathur237@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Gauhati Medical college & hospital, Guwahati- 781032, Assam , India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMISULPRIDE 5mg |
Amisulpride 5 mg single dose intravenous route of adminstration was given 30 minutes before extubation and patient was observed for 24 hours for postoperative nausea and vomiting. |
| Comparator Agent |
Ondansetron 4 mg |
Ondansetron 4mg single dose intravenous route of adminstration was given 30 minutes before extubation and patient was observed for 24 hours for postoperative nausea and vomiting. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to ASA 1 and ASA 2 category
2. Patients willing to give written informed consent
3. Patients with APFEL score 2 or more than 2. |
|
| ExclusionCriteria |
| Details |
1. Patient who received any additional drug or intervention along with the standardized anesthesia procedure during surgery. (Patients whose anesthesia procedure is deviated from routine institutional protocol.)
2. Patients with known allergy to study drugs.
3. Pregnant and lactating mothers.
4. Known psychiatric disorder on antipsychotic drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare antiemetic action of Amisulpride with Ondansetron. |
3,6,12,24 hours post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the patient post operatively for any side effects. |
3,6,12,24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
09/10/2025 |
| 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="1" Months="6" 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
|
Nausea and vomiting are very common after any major
surgical procedure. Therefore, antiemetic prophylaxis is frequently used to
reduce this complication and promote patient comfort. Amisulpride is being used
as a treatment for post operative nausea vomiting but its use as a prophylaxis
for the same is relatively less studied. The primary objective of this study is
to compare antiemetic action of 5mg IV Amisulpride over 4mg IV Ondansetron as a
prophylaxis given to adults undergoing General Anaesthesia for laparoscopic
cholecystectomy. In this study two randomized groups “A” and “O” are allocated
where Group “A’’ receives 5mg IV Amisulpride and Group “O” receives 4mg IV Ondansetron.
This Prospective Randomised Double Blind Control Study will be conducted in the
Department of Anaesthesia and Critical care, Central Hospital NF Railways over
a period of 18 months on patients of ASA Physical status I and II aged between 25-55
years. Presence of complain of nausea and vomiting, retching, need for rescue
antiemetic drug is assessed at 3h,6h,12h,24h post operatively and PONV impact
scale score calculated over 24 hours. It is hypothesized that Amisulpride is
better for prophylaxis of PONV as compared to Ondansetron. |