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CTRI Number  CTRI/2018/06/014561 [Registered on: 18/06/2018] Trial Registered Retrospectively
Last Modified On: 16/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clincal trial to compare the effect of two drugs, ondansetron and granisetron on propofol injection pain 
Scientific Title of Study   Effectiveness of pretreatment of ondansetron versus granisetron on propofol injection pain. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr vidit kaushal 
Designation  PG student 
Affiliation  B.P. Koirala Institute Of Health Scinces 
Address  B.P.K.I.H.S. Dharan, Nepal
B.P.K.I.H.S. Dharan, Nepal


110077
Other 
Phone  8527153206  
Fax    
Email  drvidit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr satyendra Narayan Singh 
Designation  professor 
Affiliation  B.P. Koirala Institute Of Health Scinces 
Address  Department of Anesthesiology and Critical Care Medicine
BPKIHS,Dharan,Nepal


7053
Other 
Phone  009779842052189  
Fax    
Email  drsnsingh_gp@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr satyendra Narayan Singh 
Designation  professor 
Affiliation  B.P. Koirala Institute Of Health Scinces 
Address  Department of Anaesthesiology and Critical Care Medicine
BPKIHS,Dharan,Nepal


7053
Other 
Phone  009779842052189  
Fax    
Email  drsnsingh_gp@yahoo.com  
 
Source of Monetary or Material Support  
B.P. KOIRALA INSTITUTE OF HEALTH SCIENCES, DHARAN, NEPAL 
 
Primary Sponsor  
Name  B P Koirala Institute Of Health Sciences 
Address  Dharan Nepal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Nepal  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr vidit Kaushal  B P Koirala Institute Of Health Sciences  Department of Anesthesiology and Critical Care Medicine. Routine Operation Theatre complex, First Floor

 		 8527153206

drvidit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA I & II patients undergoing elective surgery under general anesthesia. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  granistron  dose 1mg diluted in 1ml of 0.9% normal saline (total 2ml) given 1 minute prior to propofol injection. 
Comparator Agent  normal saline  dose 2ml of 0.9% normal saline given 1 minute prior to propofol injection. 
Comparator Agent  ondansetron  dose 4mg (2ml) given 1 minute prior to propofol injection. 
Intervention  Pretreatment of patients with ondansetron or granisetron or placebo agent ( normal saline ) prior to induction of anesthesia with propofol to see their effect on reduction in propofol injection pain.  prospective, comparative, randomized, double blind placebo controlled study was conducted within a period of 1 year after obtaining clearance from IERB of BPKIHS.One hundred twenty patients of age 18-65 years of ASA-PS I and II undergoing elective surgery under general anaesthesia were included. They were randomly divided into 3 groups with 40 in each, group A received granisetron 1mg, group B received normal saline 2ml, group C received Ondansetron 4mg. One of the 3 study drugs was administered 1 minute prior to administration of one fourth of propofol’s induction dose (2mg/kg) in 5 seconds with drip closed while asking patient about pain experienced. Rest of the induction dose was given in 15 seconds with continuously asking patent about pain. After induction fentanyl (1.5 μg/kg) and vecuronium (2mg/kg) IV was given and patients were intubated and hemodynamic parameters were recorded before induction, 1 and 3 minutes post induction than 1, 3, 5,10 minutes post intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I & II Patients undergoing elective surgery under general anesthesia 
 
ExclusionCriteria 
Details  1.Patients allergic to the study drug.
2.History of chronic pain conditions and patients on analgesics or opioids on regular basis.
3.Emergency procedures.
4.Patients of ASA physical status III or more.
5.Known or suspected pregnancy.
6.Patients with peripheral vascular disease.
7.Expected difficult intubation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of pre-treatment of intravenous ondansetron or granisetron on:
Propofol injection pain during induction of anaesthesia. 		 20 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the effect on post endotracheal intubation hemodynamic responses.  10 minutes 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/06/2013 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   no publications done till date 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Propofol is the most commonly used intravenous agent for induction of anaesthesia. It causes pain at the site of injection. Different modalities have been used in the past to abolish propofol induced pain. Recently 5-HT3 receptor antagonists like ondansetron and granisetron have shown to bind to opioid Mu receptors and exhibit agonist action. Also peripheral 5-HT3 receptors are involved in noniceptive pathways. Due to their multi faceted actions on intra-vascular Na+channels, opIoid receptors and peripheral and central 5-HT3 receptors these study drugs may potentially be used to alleviate the pain caused while injecting propofol.  In our study, we attempted to find the effectiveness of ondansetron versus granisetron in reducing propofol injection pain and the hemodynamic response during laryngoscopy and tracheal intubation after pretreatment with the study drugs.


 
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