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CTRI Number  CTRI/2025/03/083546 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A STUDY TO EVALUATE EFFICIENCY OF PALONOSETRON VS AMISULPRIDE FOR POST OPERATIVE NAUSEA AND VOMITING UNDER GENERAL ANAESTHESIA 
Scientific Title of Study   A comparative study to evaluate efficay, Of intravenous palonosetron vs amisulpride. For post operative nausea and vomiting under general anaesthesia - a randomised 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  S BALASUBRAMANIAN 
Designation  Resiedent doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  944349625  
Fax    
Email  balu94sm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dinesh Chauhan 
Designation  Professor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  9099014672  
Fax    
Email  drdinesh77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dinesh Chauhan 
Designation  Professor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  9099014672  
Fax    
Email  drdinesh77@gmail.com  
 
Source of Monetary or Material Support  
Smt.Bhikiben Kanjibai Shah Medical institiute and Research center,pipariya,waghodia,vadodara,gujarat 391760 
 
Primary Sponsor  
Name  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, 
Address  Waghodiya, Pipariya, Vadodara, Gujarat, 391760 
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 dinesh chauhan  Department of anaesthesia Smt.Bhikhiben Kanjibhai Shah Medical Institute and Research Centre  Smt.Bhikhiben Kanjibhai Shah Medical Institute and Research Centre,Pipariya,Waghodiya,Vadodara,Gujarat,India 391760
Vadodara
GUJARAT 
9099014672

drdinesh77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sumandeep vidhyapeeth institutional ethical committee  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  inj.palonosetran 0.075mg   Group A will receive palonosetran 0.075mg iv 15 min before surgery 
Comparator Agent  inj.amisulpride 5mg  Group B receive inj.amisulpride 5mg iv 15 min before surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Surgery to last at least 1 hour
2 Overnight stay
3 General anaesthesia
4 ASA I&II
5 At least one of the following Apfel et al’s risk factors for PONV:
6 Female sex
7 Non-smoking status
8 A prior history of PONV or motion sickness
9 Being expected to receive postoperative opioid analgesia 
 
ExclusionCriteria 
Details  If any antihistaminic, continuous infusion of propofol or dexmedetomidine, steroids, any antiemetics is used 24 hours prior or post-surgery then the case will be not selected for the study.
Cardiac surgery
Intrathoracic
Transplant
CNS surgery
If required post-operative ventilation
Need a nasogastric tube in situ
Parkinsons disease
Pre-existing vestibular disorder
History of dizziness
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study efficacy and safety between intravenous PALONOSETRON and AMISULPRIDE to prevent post-operative nausea vomiting.  patient will assed at 1st,2nd,6th,12th,24th hour intervels after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
•to study efficacy and safety between intravenous PALONOSETRON and AMISULPRIDE to prevent post-operative nausea vomiting.  • Efficacy was assessed during the 48 hours after administration of the study drug Episodes of emesis vomiting or retchingband the use of rescue medication were recorded. Nausea scored using a self-reported 11-point verbal scale where 0 represented no nausea and 10 was the worst nausea possible was assessed Predose at 5 15 and 30 minutes and 2 hours after administration of study medication Any nausea episodes spontaneously reported by the patient in the 48 hours was also scored and recorded. 
 
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)   10/04/2025 
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 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  

To compare antiemetic efficacy of intravenous administration of Inj.palonosetron and Inj. amisulpride for post operative nausea and vomiting under general anaesthesia.

OBJECTIVES is to study the complete response of drugs i.e. no episodes of emesis and no use of rescue medication in first 24 hours after surgery or PONV and to observe the incidence of nausea, vomiting, use of rescue medicine and any adverse events.

Inclusion criteria: Surgery to last at least 1-hour, Overnight stay, General anaesthesia, ASA I&II and At least one of the following Apfel et al

Risk factors for PONV Female sex, Non-smoking status, A prior history of PONV or motion sickness and being expected to receive postoperative opioid analgesia

Exclusion Criteria If any antihistaminic, continuous infusion of propofol or dexmedetomidine, steroids,  any antiemetics is used 24 hours prior or post-surgery then the case will be not selected for the study, Cardiac surgery, Intrathoracic, Transplant, CNS surgery, If required post-operative ventilation, Need a nasogastric tube in situ, Parkinson’s disease, Pre-existing vestibular disorder, History of dizziness, Alcohol abuse, Cardiac arrhythmia, Epilepsy, Emergency surgery, ASA III and above, Morbid obesity if weight greater than 120kg,Renal or liver disease, Pregnancy, Hypersensitivity and Known allergy

We will be conducting this on 60 adults aged 18-65yrs belonging to grade I and II of American Society of anaesthesiologists (ASA) classification who will undergo operation under general anaesthesia. They will be divided into 2 equal groups based on chit method.

Group A will receive palonosetran 0.075mg and Group B receive 5mg amisulpride and. Each group will have 30 patients based on chit method and the study drug will be administered by the consultant anaesthesiologist present in the operation theatre there. Haemodynamic parameters will be noted post-operatively at 0,2,6,8,12, 24, 48hours.Rescue antiemetic will be given upon VRS of more than or equal to 4 score i.e. moderate nausea in form of ondansetron 4 mg

Episodes of emesis (vomiting or retching) and use of rescue medication will be recorded. Nausea (scored using a self-reported 11-point verbal scale, where 0 represented no nausea and 10 the worst nausea possible) was assessed Predose and at 5, 15, and 30 minutes and 2 hours after administration of study medication. Any nausea episodes spontaneously reported by the patient in the 24-hour period will also be scored and recorded.

Site of Study Department of anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and research Centre, Piparia, Waghodia, Vadodara from 2024-2025

Study Design Prospective observational study

 

Study Duration The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or completion of time period of study whichever is earlier.

Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value <0.05 will be considered statistically significant.

LIKELY OUTCOME/BENEFITS OF STUDY We will get to know the efficacy of and safety of intravenous amisulpride as a sole agent to prevent post-operative nausea vomiting, Early ambulation of the patient and less stay in hospital and bed occupancy thus reducing economic burden.

 
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