NCT01548859

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

11 months

First QC Date

March 6, 2012

Last Update Submit

March 6, 2012

Conditions

Myocardial InjuryAnaesthetic Preconditioning

Keywords

Myocardial protectionMyocardial injuryAnaesthetic preconditioningPediatric cardiac surgeryTroponin ISevofluraneMidazolam

Outcome Measures

Primary Outcomes (1)

  • myocardial protective effect of sevoflurane

    Postoperative troponin I levels

    postoperative 48 hours

Secondary Outcomes (1)

  • Hemodynamic and respiratory data

    Postoperative 48 hours

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Sevoflurane

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Interventions

MidazolamDRUG

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

Midazolam
SevofluraneDRUG

end tidal concentration of % 0,5-8

Sevoflurane

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients scheduled for elective pediatric surgery
  • Patients written informed consent for study participation

You may not qualify if:

  • Redo surgery
  • History of myocarditis
  • Renal failure
  • Pulmonary embolism
  • Hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University, Faculty of Medicine

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Interventions

MidazolamSevoflurane

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthesiology Resident

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

TU(1)