Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000495729
Ethics application status
Approved
Date submitted
22/04/2013
Date registered
3/05/2013
Date last updated
3/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dexmeditomedine for mitral valve replacement
Scientific title
dexmeditomedine for heart rate control during mitral valve replacement for mitral stenosis a randomised controlled double blind study
Secondary ID [1] 282384 0
nil known
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients with tight mitral stenosis scheduled for mitral valve replacement 288965 0
Condition category
Condition code
Anaesthesiology 289299 289299 0 0
Anaesthetics
Cardiovascular 289300 289300 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
70 patients scheduled for mitral valve replacement divided equally into two groups were studied in this randomized controlled double blind study ; Group D : received (after induction of anesthesia) dexmeditomedine 1ug/kg bolus dose over 10 minutes followed by an infusion of 0.5 ug/kg/h till the start of cardiopulmonary bypass. Group F: received saline bolus ( after induction of anesthesia ) and infusion of saline till the start of cardiopulmonary bypass instead of dexmeditomedine .Anesthetic management for both groups was the same.
Intervention code [1] 287014 0
Treatment: Drugs
Intervention code [2] 287015 0
Prevention
Comparator / control treatment
we compared the effect of dexmeditomedine bolus and infusion on the heart rate of patients with tight mitral stenosis compared to placebo
Control group
Placebo

Outcomes
Primary outcome [1] 289407 0
heart rate changes as measured by pulse oximeter and ECG
Timepoint [1] 289407 0
the start of infusion following a bolus of dexmeditomedine after induction of anesthesia and every 10 minutes after the end of the bolus till the start of cardiopulmonary bypass
Secondary outcome [1] 302534 0
nil
Timepoint [1] 302534 0
none

Eligibility
Key inclusion criteria
patients ASAI&II with tight ( less than one centimeter ) mitral stenosis aged 18-60 years of age scheduled for mitral valve replacement
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age above or below 18-60 years , mitral valve area more than one centimeter, renal or hepatic dysfunction , cardiac medications that affect heart rate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
it is a computer generated allocation using graphpad software
allocation was concealed using sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
we used a computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Graph Pad Instat 3.0 was used to estimate sample size of 33 cases for each group (completed to 35 cases) to be sufficient for 80 % power to detect a difference of 20 % in heart rate( a difference 0f 13.6 in mean heart rate between the two groups ) and mean blood pressure (based on previously published data) under a 5% significance level ( graphPad software, San Deigo , CA, USA.)). Chi-square test was used for analysis of non-parametric data between the two groups and Mc-Nemar test for analysis within each group. Unpaired –t - test was used for analysis of parametric data between the two groups ,while paired-t-test test was used for analysis of parametric data within each group, data are expressed as mean+/- SD and P value less than 0.05 was considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/11/2011
Actual
5/11/2011
Date of last participant enrolment
Anticipated
2/05/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5040 0
Egypt
State/province [1] 5040 0
Qena - upper Egypt

Funding & Sponsors
Funding source category [1] 287157 0
University
Name [1] 287157 0
south valley university - Egypt
Country [1] 287157 0
Egypt
Primary sponsor type
Hospital
Name
south valley university -Qena university hospital
Address
Qena university hospital -Qena - P.O. 61111- Qena
Country
Egypt
Secondary sponsor category [1] 285953 0
None
Name [1] 285953 0
Address [1] 285953 0
Country [1] 285953 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39498 0
A/Prof salah mostafa asida
Address 39498 0
South Valley University -Qena faculty of medicine - department of anesthesia - P.O. 61111- Qena- Egypt
Country 39498 0
Egypt
Phone 39498 0
+201005262075
Fax 39498 0
Email 39498 0
[email protected]
Contact person for public queries
Name 39499 0
salah asida
Address 39499 0
South Valley University - Qena faculty of medicine - department of anesthesia - P.O. 61111- Qena Egypt
Country 39499 0
Egypt
Phone 39499 0
+201005262075
Fax 39499 0
Email 39499 0
[email protected]
Contact person for scientific queries
Name 39500 0
salah asida
Address 39500 0
South Valley University- Qena faculty of medicine - department of anesthesia - P.O. 61111- Qena- Egypt
Country 39500 0
Egypt
Phone 39500 0
+201005262075
Fax 39500 0
Email 39500 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.