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CTRI Number  CTRI/2024/03/064564 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
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   A Comparative study on postoperative nausea and vomitting in patients undergoing laparsocopic surgeries. 
Scientific Title of Study   A comparative study of Palonosetron And Granisetron for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgeries. 
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 Priyanka Prasannan 
Designation  Junior Resident 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No.01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9741764301  
Fax    
Email  priyansinol@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Kumar P B 
Designation  Professor and HOD 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No.01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9448279414  
Fax    
Email  drrameshkumarpb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kumar P B 
Designation  Professor and HOD 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No.01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri


KARNATAKA
560060
India 
Phone  9448279414  
Fax    
Email  drrameshkumarpb@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Insitute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India 
 
Primary Sponsor  
Name  Dr. Priyanka Prasannan 
Address  BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri 
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 Priyanka Prasannan  BGS Global Institute of Medical Sciences  Room No.01, 3rd Floor, Department of Anaesthesiology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9741764301

priyansinol@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  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  Granisetron  Single dose of IV infusion of Granisetron 40mcg/kg  
Comparator Agent  Palonosetron  Single dose IV infusion 0 of Palonosetron 0.075mg 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA Physical status I and II.
2. Elective Laparoscopic surgeries requiring general anaesthesia with endotracheal intubation and controlled ventilation.
3. Patients willing to give informed consent. 
 
ExclusionCriteria 
Details  1. ASA Physical status III and IV.
2. Patients with emetic episodes in the 24 hours prior to surgery.
3. Pregnancy or lactating mothers.
4. Emergency surgeries.
5. Patients with history of smoking or PONV or motion sickness.
6. Patients on medications that cause QT. Prolongation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative nausea and vomiting  0-2 hours, 2-6 hours, 6-24 hours, 24-48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative vitals  30mins,60mins,90 mins,120 mins,3rd hour,4th hour,5th hour,6th hour,8th hour,12th hour,16th hour,20th hour,24th hour,28th hour,32nd hour,36th hour,40th hour,44th hour,48th hour 
 
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)   01/04/2024 
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="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 along with patient dissatisfaction has many other adverse effects such as delayed recovery and extended hospital stay. The incidence of post operative nausea and vomiting was observed 30% in laparoscopic surgeries is as high as  as 70-80%. Granisetron and palonosetron are selective 5HT3 receptor antagonists that play an important role in the prophylaxis of PONV as they are more efficacious  and have lesser side effects when compared to other antiemetics. Hence the present double blind study to compare the efficacy of palanosetron and granisetron in PONV in laparoscopic surgeries. 
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