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

Myocardial Injury Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01548859
• Other study ID #: KA 11/60
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 6, 2012
• Last updated: March 6, 2012
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2012
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anaesthetic Preconditioning
• Myocardial Injury

Intervention

Drug:
• Midazolam
0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia
• Sevoflurane
end tidal concentration of % 0,5-8

Locations

Country	Name	City	State
Turkey	Baskent University, Faculty of Medicine	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial protective effect of sevoflurane	Postoperative troponin I levels	postoperative 48 hours	Yes
Secondary	Hemodynamic and respiratory data	Arterial pressure, heart rate, blood gas analysis, extubation time,	Postoperative 48 hours	Yes