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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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