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CTRI Number  CTRI/2012/01/002364 [Registered on: 23/01/2012] Trial Registered Retrospectively
Last Modified On: 23/01/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does Dexmedetomidine[a sleep inducing drug] prevent injection pain due to Propofol [an anaesthetic drug]?- a study 
Scientific Title of Study   Double blind placebo controlled study: To evaluate whether Dexmedetomidine reduces 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 Uday Ambi 
Designation  Assistant professor 
Affiliation  S N Medical college 
Address  c-17 staff qtrs, S N Medical college campus navanagar, Bagalkot
Dept.of Anaesthesiology S N Medical college Navanagar,Bagalkot
Bagalkot
KARNATAKA
587102
India 
Phone  9880570780  
Fax    
Email  udayambi@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uday Ambi 
Designation  Assistant professor 
Affiliation  S N Medical college 
Address  c-17 staff qtrs, S N Medical college campus navanagar, Bagalkot
Dept.of Anaesthesiology S N Medical college Navanagar,Bagalkot

KARNATAKA
587102
India 
Phone  9880570780  
Fax    
Email  udayambi@ymail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Uday Ambi 
Designation  Assistant professor 
Affiliation  S N Medical college 
Address  c-17 staff qtrs, S N Medical college campus navanagar, Bagalkot
Dept.of Anaesthesiology S N Medical college Navanagar,Bagalkot

KARNATAKA
587102
India 
Phone  9880570780  
Fax    
Email  udayambi@ymail.com  
 
Source of Monetary or Material Support  
S N Medical college,Bagalkot 
 
Primary Sponsor  
Name  S N Medical college 
Address  Navanagar,bagalkot 
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 Uday Ambi  Department of Anaesthesiology  S N Medical college navanagar,bagalkot
Bagalkot
KARNATAKA 
9880570780

udayambi@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S N Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients coming for surgery under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  0.5 microgram/kg of intravenous Dexmedetomidine injected at a rate of 0.5ml/sec after applying tourniquet, then tourniquet released,IV Propofol 3ml given 
Comparator Agent  saline  0.5 microgram/kg of intravenous saline injected at a rate of 0.5ml/sec after applying tourniquet, then tourniquet released,IV Propofol 3ml given 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II patients undergoing general anaesthesia
 
 
ExclusionCriteria 
Details  paediatric patients
ASA III and IV patients
patients allergic to Dexmedetimidine
Neuropsychiatric patients
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
proportion of patients attaining pain relief for injection pain due to propofol  5min 
 
Secondary Outcome  
Outcome  TimePoints 
proportion of patients showing reduced withdrawal movements to propofol injection  5min 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   15/12/2011 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   It is well known fact that propofol causes pain when injected intravenously. Several agents are used to reduce this pain. This prospective, double blind, placebo controlled trail is designed to determine the efficacy of Dexmedetomidine in reducing the propofol injection pain. 
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