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CTRI Number  CTRI/2018/04/012965 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 23/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of drugs for post operative nausea and vomiting after laproscopic surgeries 
Scientific Title of Study   A comparison of Ondansetron, Palonosetron and Granisetron for Prevention of Post-operative nausea and vomiting after Laparoscopic Surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruchika Kathuria 
Designation  Post- Diploma DNB Resident 
Affiliation  BPS GMC Khanpur Kalan 
Address  Department of Anaesthesiology, Main OT Complex, BPS GMC Khanpur Kalan, Sonipat

Sonipat
HARYANA
131305
India 
Phone  8053440544  
Fax  01263283064  
Email  ruchikakathuria15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pranav Bansal 
Designation  Professor and HOD 
Affiliation  BPS GMC Khanpur Kalan 
Address  Department of Anaesthesiology, Main OT Complex, BPS GMC Khanpur Kalan, Sonipat

Sonipat
HARYANA
131305
India 
Phone  82220075  
Fax  01263283064  
Email  pranavbansal1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ruchika Kathuria 
Designation  Post- Diploma DNB Resident 
Affiliation  BPS GMC Khanpur Kalan 
Address  Department of Anaesthesiology, Main OT Complex, BPS GMC Khanpur Kalan, Sonipat

Sonipat
HARYANA
131305
India 
Phone  8053440544  
Fax  01263283064  
Email  ruchikakathuria15@gmail.com  
 
Source of Monetary or Material Support  
BPS Government Medical College for Women,Khanpur Kalan, Sonipat 
 
Primary Sponsor  
Name  BPS GMC Khanpur Kalan 
Address  Bhagat Phool Singh Govt. Medical College Khanpur Kalan Sonipat Haryana 131305 
Type of Sponsor  Government 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 
RUCHIKA KATHURIA  BPS GMC KHANPUR  Main Operation Theatre complex Post-operative anaesthesia care unit(PACU)/ ward Bhagat Phool Singh Govt. Medical College for Women, Khanpur Kalan
Sonipat
HARYANA 		 8053440544

ruchikakathuria15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTUTIONAL ETHICS COMMITTEE OF BPS GOVT.MEDICAL COLLEGE FOR WOMEN, KHANPUR KALAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS UNDERGOING LAPAROSCOPIC SURGERY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of either ondansetron, palonosetron or granisetron   Prophylactic administration of either ondansetron, palonosetron or granisetron prior to induction agent by Intravenous(iv) route. Inj. Ondansetron 8 mg iv Inj. Palonosetron 0.075 mg iv Imj. Granisetron 2.5 mg iv  
Comparator Agent  Drugs used are Ondansetron, Palonosetron and Granisetron   Comparison of ondansetron, palonosetron and granisetron in patients undergoing laparoscopic surgeries. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA grade I/II patients.
2.Patient receiving general anaesthesia for laparoscopic surgery

 
 
ExclusionCriteria 
Details  1.Refusal to participate in the study
2.Patients less than 18 or more than 65 years of age
3.Pregnant and lactating females
4.Morbid obesity (BMI>40 kg/m2)
5.Allergy to any of the anti-emetic drugs
6.History of PONV and motion sickness
7.Use of anti-emetic medication within 6 h prior to surgery
8.Use of high dose opioids prior to surgery
9.Patients with history of motion sickness, endocrine or metabolic disorders, hepatic or renal disease, gastrointestinal disorders and psychiatric diseases.
 
 
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 
To evaluate and compare the efficacy of ondansetron with palonosetron, and ondansetron with granisetron in prevention of Post-Operative Nausea and Vomiting (PONV).

 		 prevention of nausea and vomiting for upto 24 hours after surgery

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the side effect and haemodynamic profile on use of ondansetron, palonosetron and granisetron in patients undergoing laparoscopic surgeries under general anaesthesia.
2. To evaluate patient satisfaction scores.
 		 INTRAOPERATIVE AND 24 HRS POST OPERATIVE 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   05/02/2018 
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)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Post-operative nausea and vomiting (PONV) has been an important concern in patients undergoing  laparoscopic surgeries. Multiple agents have been used to treat PONV but 5-HT3 receptor antagonists are found be more effective with their potent anti-emetic effects. In our study, we aim to compare the effectiveness of ondansetron with different 5-HT3 receptor antagonists: palonosetron, and granisetron. A total of 135 patients will be randomly allocated into 3 groups with 45 patients in each group. Group O will receive Inj. Ondansetron 8mg intravenously, Group P will receive Inj. Palonosetron 0.075mg intravenously, and Group G will receive Inj. Granisetron 2.5mg intravenously prior to induction of anaesthesia. Patients will be monitored intraoperatively for vital parameters including heart rate, blood pressure, and oxygen saturation and postoperatively for possible side-effects of these agents including nausea, vomiting, headache, dizziness, allergy, constipation, etc. Thereafter, comparisons will be made among the two groups based on the data collected. The different variables and occurrence of side effects, if any, would also be noted and compared amongst all groups. Since this is a randomized prospective trial, the anticipated outcome cannot be commented upon.

 
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