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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Huseyin Utku YILDIRIM, Baskent University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548859
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Huseyin Utku YILDIRIM, Baskent University
March 6, 2012
March 8, 2012
March 8, 2012
July 2011
June 2012   (Final data collection date for primary outcome measure)
myocardial protective effect of sevoflurane [ Time Frame: postoperative 48 hours ]
Postoperative troponin I levels
Same as current
No Changes Posted
Hemodynamic and respiratory data [ Time Frame: Postoperative 48 hours ]
Arterial pressure, heart rate, blood gas analysis, extubation time,
Same as current
Not Provided
Not Provided
 
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
Not Provided
The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Myocardial Injury
  • Anaesthetic Preconditioning
  • Drug: Midazolam
    0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia
  • Drug: Sevoflurane
    end tidal concentration of % 0,5-8
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Month to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01548859
KA 11/60
Yes
Not Provided
Not Provided
Huseyin Utku YILDIRIM, Baskent University
Baskent University
Not Provided
Not Provided
Baskent University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP