Overview

This trial is active, not recruiting.

Conditions myocardial injury, anaesthetic preconditioning
Treatments midazolam, sevoflurane
Phase phase 4
Sponsor Baskent University
Start date July 2011
End date June 2012
Trial size 50 participants
Trial identifier NCT01548859, KA 11/60

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Used for maintenance anaesthesia (0.2 mg/kg/saat continuous infusion)
midazolam
0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia
(Active Comparator)
Used for the maintenance for anaesthesia (% 0.5-8 end tidal concentration)
sevoflurane
end tidal concentration of % 0,5-8

Primary Outcomes

Measure
myocardial protective effect of sevoflurane
time frame: postoperative 48 hours

Secondary Outcomes

Measure
Hemodynamic and respiratory data
time frame: Postoperative 48 hours

Eligibility Criteria

Male or female participants from 1 month up to 6 years old.

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 information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Baskent University.