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

NCT ID: NCT01548859

Last Updated: 2012-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Myocardial Injury Anaesthetic Preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia

Sevoflurane

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

end tidal concentration of % 0,5-8

Interventions

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Midazolam

0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia

Intervention Type DRUG

Sevoflurane

end tidal concentration of % 0,5-8

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Huseyin Utku YILDIRIM

Anaesthesiology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baskent University, Faculty of Medicine

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KA 11/60

Identifier Type: -

Identifier Source: org_study_id

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