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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

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ClinicalTrials.gov Identifier: NCT01548859
Recruitment Status : Unknown
Verified March 2012 by Huseyin Utku YILDIRIM, Baskent University.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):
Huseyin Utku YILDIRIM, Baskent University

Brief Summary:
The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery

Condition or disease Intervention/treatment Phase
Myocardial Injury Anaesthetic Preconditioning Drug: Midazolam Drug: Sevoflurane Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : July 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Midazolam
Used for maintenance anaesthesia (0.2 mg/kg/saat continuous infusion)
Drug: Midazolam
0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia
Active Comparator: Sevoflurane
Used for the maintenance for anaesthesia (% 0.5-8 end tidal concentration)
Drug: Sevoflurane
end tidal concentration of % 0,5-8



Primary Outcome Measures :
  1. myocardial protective effect of sevoflurane [ Time Frame: postoperative 48 hours ]
    Postoperative troponin I levels


Secondary Outcome Measures :
  1. Hemodynamic and respiratory data [ Time Frame: Postoperative 48 hours ]
    Arterial pressure, heart rate, blood gas analysis, extubation time,



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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548859


Locations
Turkey
Baskent University, Faculty of Medicine
Ankara, Çankaya, Turkey, 06490
Sponsors and Collaborators
Baskent University

Responsible Party: Huseyin Utku YILDIRIM, Anaesthesiology Resident, Baskent University
ClinicalTrials.gov Identifier: NCT01548859     History of Changes
Other Study ID Numbers: KA 11/60
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Huseyin Utku YILDIRIM, Baskent University:
Myocardial protection
Myocardial injury
Anaesthetic preconditioning
Pediatric cardiac surgery
Troponin I
Sevoflurane
Midazolam

Additional relevant MeSH terms:
Anesthetics
Midazolam
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation