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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 because the information has not been verified recently.
Verified March 2012 by Baskent University.
Recruitment status was  Active, not recruiting
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

March 6, 2012
March 6, 2012
July 2011
June 2012   (final data collection date for primary outcome measure)
myocardial protective effect of sevoflurane [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ]
Postoperative troponin I levels
Same as current
No Changes Posted
Hemodynamic and respiratory data [ Time Frame: Postoperative 48 hours ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Active, not recruiting
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
Both
1 Month to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01548859
KA 11/60
Yes
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