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CTRI Number  CTRI/2025/09/094850 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of amisulpride with ondansetron versus dexamethasone with ondansetron in prevention of post operative nausea and vomiting in patients going for gall bladder removal surgeries. 
Scientific Title of Study   Intravenous Amisulpride with intravenous Ondansetron versus intravenous Dexamethasone with intravenous Ondansetron in prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A Double-Blind 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  Lavanya Parashar 
Designation  Resident 
Affiliation  Shri Guru Ram Rai Institute Of Medical And Health Sciences, dehradun 
Address  Department of Anaesthesia , Shri Guru Ram Rai Institute of Medical and Health Sciences , Dhradun , Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  9012300333  
Fax    
Email  lavanyaparashar29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashutosh Singh 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun 
Address  Department Of Anaesthesia , Shri Guru Ram Rai Institute of Medical and Health SCiences , Dehradun , Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  9540947103  
Fax    
Email  drashutoshsingh17@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashutosh Singh 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun 
Address  Department Of Anaesthesia , Shri Guru Ram Rai Institute of Medical and Health SCiences , Dehradun , Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  9540947103  
Fax    
Email  drashutoshsingh17@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology , Shri Guru Ram Rai Institute Of Medical and Health Sciences, Patel Nagar, Dehradun , Uttarakhand , India (248001) 
 
Primary Sponsor  
Name  Dr Ashutosh Singh 
Address  Shri Guru Ram Rai Institute Of Medical And Health sciences , Patel nagar, Dehradun, India (248001) 
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 Lavanya Parashar  Shri Guru Ram Rai Medical College , Dehradun  Department Of Anaesthesia , Shri Guru Ram Rai Institute Of Medical and Health Sciences , Dehradun
Dehradun
UTTARANCHAL 		 9012300333

lavanyaparashar29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutiona Ethics Committee Shri Guru Ram Rai Institute of Medical And Health Sciences , Patel Nagar , Dehradun  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Amisulpride with intravenous Ondansetron  Intravenous Amisulpride 5mg bolus with intravenous Ondansetron 4mg bolus will be given in first 30min of surgery total lasting for 1hour 
Comparator Agent  Intravenous Dexamethasone with intravenous Ondansetron  Intravenous Dexamethasone 8mg bolus with intravenous Ondansetron 4mg bolus in first 30min of surgery lasting for 1hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Scheduled to undergo elective laparoscopic cholecystectomy under general anaesthesia lasting for atleast 1 hour under GA with inhalational agent.
2) Ability to provide informed consent for participation in the study.
 
 
ExclusionCriteria 
Details  1) Patients with a history of severe adverse reactions to any of the study medications.
2) Known hypersensitivity to any of the study drugs.
3) History of significant cardiac, renal, hepatic, or neurological disorders.
4) Pregnancy or breastfeeding.
5) Use of antiemetic medications within 24 hours prior to surgery.
6) Chronic opioid use or history of substance abuse.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the incidence of emetic episodes within 24 hours post-surgery in both treatment groups.
2) To assess the severity of nausea at 1, 2, 6 and 24 hours post-surgery in both treatment groups using a patient verbal rating scale.
3) To predict the incidence of PONV using the Apfel scoring system in both treatment groups.
 		 To assess at 1st, 2nd, 6th and 24th hour post-surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the need for rescue medication for PONV in each treatment groups
 		 Within 24hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   29/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Post operative nausea and vomiting(PONV) is a common and distressing complication following surgical procedures affecting approximately 20-30% of patients despite advancements in anaesthesia and pre operative care. it is distressing for patients and increases the risk of other adverse events. PONV results from a complex interplay of multiple factors including patients characteristics, surgical factors, anaesthetic agents and preoperative interventions. risk factors such as female gender , history of PONV and motion sickness, non smoking status ,younger age, type and duration of surgery, use of volatile anaesthetics and opioid analgesia
Dexamethasone is a potent corticosteroid with anti inflammatory and immunosupressive properties has emerged as a promising agent for PONV. its ability to modulate multiple pathways involved in pathogenesis of PONV has led to its wide spread use in perioperative care. 
Amisulpride is a atypical antipsychotic agent used in treatment of psychiatric disorders such as schizophrenia and bipolar disorder has gained interest in potential role of PONV. studies has shown efficacy of the drug in preventing chemotherapy induced nausea vomiting which shares common pathway with PONV.
The goal of study is the compare the efficacy and safety of intravenous amisulpride with intravenous ondansatron and intravenous dexamethasone with intravenous ondansetron in PONV in patients undergoing elective laparoscopic cholecystectomy.
 
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