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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
  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
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Huseyin Utku YILDIRIM, Anaesthesiology Resident, Baskent University
ClinicalTrials.gov Identifier: NCT01548859     History of Changes
Other Study ID Numbers: KA 11/60
First Submitted: March 6, 2012
First Posted: March 8, 2012
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