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CTRI Number  CTRI/2025/10/096299 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison between Amisulpride and Ondansetron as an antiemetic for alleviating postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy 
Scientific Title of Study   Comparison between Amisulpride and Ondansetron as an antiemetic for alleviating postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy 
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 Sheetal Khattri 
Designation  Postgraduate Resident 
Affiliation  Himalayan institute of medical sciences 
Address  Department of Anesthesia, Himalayan institute of medical sciences, Dehradun, Uttarakhand, India

Dehradun
UTTARANCHAL
248140
India 
Phone  9168212171  
Fax    
Email  9khattrisheetal4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Asthana 
Designation  Professor 
Affiliation  Himalayan institute of medical sciences 
Address  Department of Anesthesia, Himalayan institute of medical sciences, Dehradun, Uttarakhand, India

Dehradun
UTTARANCHAL
248140
India 
Phone  9719529195  
Fax    
Email  veenaasthana@srhu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Veena Asthana 
Designation  Professor 
Affiliation  Himalayan institute of medical sciences 
Address  Department of Anesthesia, Himalayan institute of medical sciences, Dehradun, Uttarakhand, India

Dehradun
UTTARANCHAL
248140
India 
Phone  9719529195  
Fax    
Email  veenaasthana@srhu.edu.in  
 
Source of Monetary or Material Support  
Himalayan institute of medical sciences, Jolly Grant, Dehradun 
 
Primary Sponsor  
Name  Swami Rama Himalayan Institute 
Address  Himalayan Institute of medical sciences, Jolly Grant, Uttarakhand, India 248140 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Veena Asthana  Himalayan institute of medical sciences  Department of anesthesia first floor operation theatre himalayan hospital, SRHU Campus, Dehradun
Dehradun
UTTARANCHAL 		 01352471158

veenaasthana@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection Amisulpride 5mg   at the time of induction 
Comparator Agent  Injection Ondansetron 1mg/kg  30 mins before the end of surgery 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Physical status I or II
Undergoing elective laparoscopic cholecystectomy
willing to provide written informed consent 
 
ExclusionCriteria 
Details  refusal to participate
history of drug allergy to amisulpride or ondansetron
pregnancy or gastroesophageal reflux disease
history of cardiopulmonary diseases (asthma, COPD)
Preoperative renal/hepatic dysfunction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. to evaluate the effectiveness of two antiemetics- ondansetron (1mg/kg) and amisulpride (5mg)- in controlling post operative nausea and vomiting after laparoscopic cholecystectomy
-to assess hemodynamic fluctuations and the side effects of ondansetron and amisulpride
-to assess the effectiveness of amisulpride and ondansetron preoperatively and postoperatively using quality of recovery 15 score 		 1. immediately after extubation
2. within 6 hours of extubation
3. within 12 hours of extubation
4. within 24 hours of extubation 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   23/11/2025 
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="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   Laparoscopic cholecystectomy is now a procedure of choice for cholelithiasis and chronic cholecystitis. Laparoscopic procedures are being done under general anesthesia with muscle paralysis and controlled ventilation.Postoperative nausea and vomiting (PONV) is a common and a distressing complication after surgery. PONV maybe mild or transient, but its impact on patients can be much more severe, it can cause inability to mobilize after surgery, restricted oral intake, complications of protracted vomiting and delayed recovery and discharge after surgery. The main objective of the study is to compare between amisulpride and ondansetron as an antiemetic for alleviating PONV in patients undergoing Laparoscopic cholecystectomy.
   
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