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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Cerebral Oxygenation

Treatments: Drug: nitroprusside; Drug: sevoflurane; Drug: nitroglycerine

Study type: Interventional

Funder types: Other

Identifiers

NCT00535808

2007/270

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Experimental group

Description:

Administration of nitroprusside

Treatment:

Drug: nitroprusside

2

Experimental group

Description:

Administration of nitroglycerine

Treatment:

Drug: nitroglycerine

3

Experimental group

Description:

Administration of sevoflurane

Treatment:

Drug: sevoflurane