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Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study

Phase 2
Completed
Conditions
Cerebral Oxygenation
Interventions
Registration Number
NCT00535808
Lead Sponsor
University Hospital, Ghent
Brief Summary

In a prospective and randomized study protocol, three different blood pressure regulating agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect on the cerebral oxygen balance between both hemispheres during aortic coarctation repair. Cerebral and somatic saturation will be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and the somatic regions. Arterial blood pressure, central venous pressure, heart rate and systemic saturation will be recorded continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6 definite time intervals. The study ends at the end of the operation.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • All neonates and infants
  • Aged 0-18 year
  • With aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass will be included.
Exclusion Criteria
  • All patients with an associated cardiac effect are excluded.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
2nitroglycerineAdministration of nitroglycerine
1nitroprussideAdministration of nitroprusside
3sevofluraneAdministration of sevoflurane
Primary Outcome Measures
NameTimeMethod
Cerebral saturationDuring operation
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital Ghent

🇧🇪

Ghent, Belgium

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