Moyamoya Disease
Conditions
Brief summary
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.
Interventions
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.
PROCEDUREBlood Pressure-Guided Standard Hemodynamic Management
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of transient ischemic episodes during hospitalization | Postoperative hospital stay | From end of surgery through postoperative hospital discharge, up to 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI-confirmed intracranial hemorrhage | From postoperative Day 0 through Day 7 | — |
| Length of hospital stay | From postoperative Day 0 through Day 7 | Total number of days from the date of surgery to discharge. |
| Intraoperative fluid volume administered | Intraoperative period | Total amount of crystalloid and colloid administered during surgery. |
| Intraoperative vasoactive agent dose | Intraoperative period | Total dose of vasoactive medications administered during anesthesia. |
| Intraoperative urine output | Intraoperative period | Total urine output measured during surgery. |
| MRI-confirmed postoperative cerebral infarction | From postoperative Day 0 through Day 7 | — |
| Duration of anesthesia | Intraoperative period | Time from induction of anesthesia to completion of anesthesia. |
| Duration of postoperative mechanical ventilation | From end of surgery until extubation, assessed up to 24 hours | Total duration of mechanical ventilation following surgery. |
| Length of ICU stay | From postoperative Day 0 through ICU discharge, assessed up to 14 days | Number of days spent in the ICU after surgery. |
| Percentage of anesthesia time with MAP deviating >20% from baseline | Intraoperative period | Proportion of total anesthesia time during which mean arterial pressure deviates more than 20% from the patient's ward baseline MAP. |
| Percentage of anesthesia time with cardiac index deviating >20% from baseline | Intraoperative period | Proportion of total anesthesia time during which cardiac index deviates more than 20% from the patient's baseline cardiac index measured via preoperative echocardiography. |
| Estimated blood loss | Intraoperative period | Total estimated blood loss recorded during the surgical procedure. |
Countries
South Korea
Contacts
Primary ContactJung-Bin Park
Outcome results
None listed