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

• Sponsor: Baskent University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01548859
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Injury; Anaesthetic Preconditioning	Drug: Midazolam; Drug: Sevoflurane	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Jul 1, 2011
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. myocardial protective effect of sevoflurane [postoperative 48 hours]

   Postoperative troponin I levels

Secondary Outcome Measures

1. Hemodynamic and respiratory data [Postoperative 48 hours]

   Arterial pressure, heart rate, blood gas analysis, extubation time,

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 6 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Baskent University, Faculty of Medicine	Ankara	Çankaya	Turkey	06490

Sponsors and Collaborators

• Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huseyin Utku YILDIRIM, Anaesthesiology Resident, Baskent University
• ClinicalTrials.gov Identifier: NCT01548859
• Other Study ID Numbers: KA 11/60
• First Posted: Mar 8, 2012
• Last Update Posted: Mar 8, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Huseyin Utku YILDIRIM, Anaesthesiology Resident, Baskent University: Myocardial protection; Myocardial injury; Anaesthetic preconditioning; Pediatric cardiac surgery; Troponin I; Sevoflurane; Midazolam
• Additional relevant MeSH terms: Midazolam; Sevoflurane

Study Results

No Results Posted as of Mar 8, 2012