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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

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
  Purpose

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


Condition Intervention Phase
Myocardial Injury
Anaesthetic Preconditioning
 Drug: Midazolam
Drug: Sevoflurane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Baskent University:

Primary Outcome Measures:
  • myocardial protective effect of sevoflurane [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ]
    Postoperative troponin I levels


Secondary Outcome Measures:
  • Hemodynamic and respiratory data [ Time Frame: Postoperative 48 hours ] [ Designated as safety issue: Yes ]
    Arterial pressure, heart rate, blood gas analysis, extubation time,


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548859

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

No publications provided

Responsible Party: Huseyin Utku YILDIRIM, Anaesthesiology Resident, Baskent University
ClinicalTrials.gov Identifier: NCT01548859     History of Changes
Other Study ID Numbers: KA 11/60
Study First Received: March 6, 2012
Last Updated: March 6, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on June 18, 2013