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

Baskent University

Status and phase: Unknown; Phase 4

Conditions: Myocardial Injury; Anaesthetic Preconditioning

Treatments: Drug: Sevoflurane; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01548859

KA 11/60

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Midazolam

Active Comparator group

Description:

Used for maintenance anaesthesia (0.2 mg/kg/saat continuous infusion)

Treatment:

Drug: Midazolam

Sevoflurane

Active Comparator group

Description:

Used for the maintenance for anaesthesia (% 0.5-8 end tidal concentration)

Treatment:

Drug: Sevoflurane