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

Condition(s) targeted: Cerebral Oxygenation

Intervention: nitroprusside (Drug); nitroglycerine (Drug); sevoflurane (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Annelies Moerman, MD, Principal Investigator, Affiliation: University Hospital, Ghent

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cerebral saturation

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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.

University Hospital Ghent, Ghent 9000, Belgium

Website of the University Hospital Ghent

Starting date: October 2007
Last updated: July 12, 2012