Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

Seoul National University

Status: Enrolling

Conditions: Moyamoya Disease

Treatments: Procedure: Cardiac Index-Guided Hemodynamic Management; Procedure: Blood Pressure-Guided Standard Hemodynamic Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07304947

H-2411-122-1591

Details and patient eligibility

About

This prospective randomized controlled trial evaluates whether individualized cardiac index-guided intraoperative hemodynamic management reduces postoperative transient ischemic episodes in pediatric patients undergoing encephaloduroarteriosynangiosis (EDAS) for Moyamoya disease. Patients are randomized 1:1 to goal-directed fluid therapy based on baseline cardiac index versus standard arterial pressure-based management. The primary outcome is the incidence of transient ischemic episodes during hospitalization.

Enrollment: 94 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients <18 years undergoing EDAS for Moyamoya disease under general anesthesia

Exclusion criteria

• ASA physical status 4-5
• Emergency surgery
• Known cardiovascular disease
• Any condition judged inappropriate by investigators

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Cardiac index guided hemodynamic management

Experimental group

Treatment:

Procedure: Cardiac Index-Guided Hemodynamic Management

Blood pressure guided hemodynamic management

Active Comparator group

Treatment:

Procedure: Blood Pressure-Guided Standard Hemodynamic Management