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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
Information provided by (Responsible Party):
Huseyin Utku YILDIRIM, Baskent University Identifier:
First received: March 6, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Huseyin Utku YILDIRIM, Baskent University:

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

Secondary Outcome Measures:
  • Hemodynamic and respiratory data [ Time Frame: Postoperative 48 hours ]
    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


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

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
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Please refer to this study by its identifier: NCT01548859

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

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

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

Additional relevant MeSH terms:
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 processed this record on August 21, 2017