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CTRI Number  CTRI/2024/06/069635 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Amisulpride and Granisetron for prevention of postoperative nausea and vomiting after high risk surgery undergoing general anesthesia. 
Scientific Title of Study   Comparative study between Amisulpride and Granisetron for prevention of postoperative nausea and vomiting in patient undergoing general Anaesthesia: A Rndomized Controlled 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  Jay prakash ravi 
Designation  MD trainee 
Affiliation  IGIMS patna 
Address  Department of anaesthesiology and CCM,1st floor ward block,igims

Patna
BIHAR
800014
India 
Phone  9122593995  
Fax    
Email  jaiprakash248@live.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bibha kumari 
Designation  Associate Professor 
Affiliation  IGIMS patna 
Address  Department of anaesthesiology and CCM,1st floor ward block,igims

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jay prakash ravi 
Designation  MD trainee 
Affiliation  IGIMS patna 
Address  Department of anaesthesiology and CCM,1st floor ward block,igims


BIHAR
800014
India 
Phone  9122593995  
Fax    
Email  jaiprakash248@live.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute Of Medical Sciences, Patna,Bihar, 800014 
 
Primary Sponsor  
Name  Dr Jay Prakash Ravi 
Address  Indira Gandhi Institute Of Medical Sciences, Patna,Bihar, 800014 
Type of Sponsor  Other [self] 
 
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 Jay Pakash Ravi  Indira Gandhi Institute Of Medical Sciences  Gastro Surgery OTcomplex 1,2,3,4. Patna,Bihar, 800014
Patna
BIHAR 		 9122593995

jaiprakash248@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee,IGIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Amisulpride 5mg/2ml  Amisulpride 5mg/2ml (Trade name Sultaren manufactured by La Renon ltd, India.) with 8mg dexamethasone. Dose- 5mg as a single intravenous injection infused over 1-2 minutes just before induction of anesthesia. 
Comparator Agent  Injection Granisetron 3mg/3ml  Injection Granisetron 3mg/3ml (Trade name Granicip manufactured by cipla ltd, India) with 8 mg dexamethasone Dose- 1mg intravenous infusion over 30 second just before induction of anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate.
2.Patients 18-70 years of age of either gender.
3.ASA grade 1-3 patients.
4.Operative procedure requiring General Anaesthesia.
 
 
ExclusionCriteria 
Details  Any contraindications to General Anaesthesia.
1.Patients with history of motion sickness.
2.Patients with pregnancy.
3.Lactating Mother.
4.Patients on chronic anti emetic medications.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the incidence of PONV in patients undergoing General anesthesia.   Time interval 0-6 hr,6-12 hr,12-24hr 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the secondary efficacy variables i.e.

1.Post operative need of anti-emetics.
2.Adverse effects, if any.

 		 1 year 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 4 
Date of First Enrollment (India)   20/07/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jaiprakash248@live.com].

  6. For how long will this data be available start date provided 20-06-2024 and end date provided 30-04-0027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Nausea and vomiting are two of the most unpleasant and distressing event in the postoperative period with an estimated incidence of 30% in general surgical patients and as high as 80% in high risk groups.
  Incidence of post operative nausea and vomiting (PONV) in high risk surgeries is very high.High risk surgeries include cholecystectomy and gyneocological and laparoscopic surgeries.Long duration surgeries are associated with increase incidence of PONV.increasing operative duration by 30 minutes may increase the risk of PONV . Increasing operative duration by 30 minutes may increase the risk of PONV by 60%. Repeated PONV can lead to more serious and undesirable consequences such as dehydration, electrolyte imbalance, increased post operative pain and aspiration of gastric content.
  In this study we will be comparing amisulpride dopamine D2 receptor antagonist with granisetron 5-HT3 receptor antagonist for prevention of PONV in high surgery after general anaesthesia.
 
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