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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
94
In the experimental arm, intraoperative hemodynamic management is guided by each patient's baseline cardiac index. Cardiac output is continuously monitored using the LiDCO system after arterial line insertion. Baseline cardiac index is calibrated using transthoracic echocardiography, and intraoperative fluids and vasoactive agents are adjusted to maintain cardiac index within ±20% of baseline. Standard anesthesia monitoring is provided to all patients.
In the control arm, intraoperative hemodynamic management follows conventional blood pressure-guided practice. After arterial line placement, the LiDCO device remains connected but the display is concealed during anesthesia. Fluids and vasoactive medications are adjusted according to standard MAP-based management. Standard anesthesia monitoring is provided to all patients.
Seoul National University Children's Hospital
Seoul, South Korea
RECRUITINGIncidence of transient ischemic episodes during hospitalization
From end of surgery through postoperative hospital discharge, up to 7 days
Time frame: Postoperative hospital stay
MRI-confirmed postoperative cerebral infarction
Time frame: From postoperative Day 0 through Day 7
MRI-confirmed intracranial hemorrhage
Time frame: From postoperative Day 0 through Day 7
Length of hospital stay
Total number of days from the date of surgery to discharge.
Time frame: From postoperative Day 0 through Day 7
Intraoperative fluid volume administered
Total amount of crystalloid and colloid administered during surgery.
Time frame: Intraoperative period
Intraoperative vasoactive agent dose
Total dose of vasoactive medications administered during anesthesia.
Time frame: Intraoperative period
Intraoperative urine output
Total urine output measured during surgery.
Time frame: Intraoperative period
Estimated blood loss
Total estimated blood loss recorded during the surgical procedure.
Time frame: Intraoperative period
Duration of anesthesia
Time from induction of anesthesia to completion of anesthesia.
Time frame: Intraoperative period
Duration of postoperative mechanical ventilation
Total duration of mechanical ventilation following surgery.
Time frame: From end of surgery until extubation, assessed up to 24 hours
Length of ICU stay
Number of days spent in the ICU after surgery.
Time frame: From postoperative Day 0 through ICU discharge, assessed up to 14 days
Percentage of anesthesia time with MAP deviating >20% from baseline
Proportion of total anesthesia time during which mean arterial pressure deviates more than 20% from the patient's ward baseline MAP.
Time frame: Intraoperative period
Percentage of anesthesia time with cardiac index deviating >20% from baseline
Proportion of total anesthesia time during which cardiac index deviates more than 20% from the patient's baseline cardiac index measured via preoperative echocardiography.
Time frame: Intraoperative period
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