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
|
|
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
|
|
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. |