Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Huseyin Utku YILDIRIM, Baskent University

ClinicalTrials.gov Identifier:

NCT01548859

First received: March 6, 2012

Last updated: NA

Last verified: March 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 6, 2012
Last Updated Date	March 6, 2012
Start Date ^ICMJE	July 2011
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2012)	myocardial protective effect of sevoflurane [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ] Postoperative troponin I levels
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2012)	Hemodynamic and respiratory data [ Time Frame: Postoperative 48 hours ] [ Designated as safety issue: Yes ] Arterial pressure, heart rate, blood gas analysis, extubation time,
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Myocardial Injury Anaesthetic Preconditioning
Intervention ^ICMJE	Drug: Midazolam 0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia Drug: Sevoflurane end tidal concentration of % 0,5-8
Study Arm (s)	Active Comparator: Midazolam Used for maintenance anaesthesia (0.2 mg/kg/saat continuous infusion) Intervention: Drug: Midazolam Active Comparator: Sevoflurane Used for the maintenance for anaesthesia (% 0.5-8 end tidal concentration) Intervention: Drug: Sevoflurane
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients scheduled for elective pediatric surgery Patients written informed consent for study participation Exclusion Criteria: Redo surgery History of myocarditis Renal failure Pulmonary embolism Hypothyroidism
Gender	Both
Ages	1 Month to 6 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Turkey

Administrative Information
NCT Number ^ICMJE	NCT01548859
Other Study ID Numbers ^ICMJE	KA 11/60
Has Data Monitoring Committee	Yes
Responsible Party	Huseyin Utku YILDIRIM, Baskent University
Study Sponsor ^ICMJE	Baskent University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Baskent University
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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