Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058926) titled 'Emergence agitation after pediatric general anesthesia and its relationship with HFVI' on Sept. 1.

Study Type: Observational

Primary Sponsor: Institute - Showa University

Condition: Condition - Pediatric patients aged 2 to 10 years, classified as ASA physical status I or II, scheduled to undergo inguinal hernia repair or tonsillectomy under general anesthesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to clarify whether the High Frequency Variability Index (HFVI) is associated with the development of emergence delirium (ED) in pediatric patients. HFVI is a noninvasive indicator of parasympathetic nervous activity, and its use may enhance the prediction of ED risk and the possibility of preventive interventions. Establishing a predictive marker for ED is expected to contribute to improving the quality and safety of pediatric anesthesia. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 2 years-old = Gender - Male and Female Key inclusion criteria - Pediatric patients aged 2 to 10 years, classified as ASA physical status I or II, scheduled to undergo inguinal hernia repair or tonsillectomy under general anesthesia at Showa University Yokohama North Hospital Key exclusion criteria - Patients with a history of cardiac, respiratory, or neurological disorders that may affect HFVI

Patients for whom assessment of the PAED score is difficult, such as those with developmental delay

Patients with a previous history of emergence-related problems under general anesthesia

Patients whose legal guardians are unable to provide written informed consent Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 29 Day Date of IRB - 2025 Year 08 Month 22 Day Anticipated trial start date - 2025 Year 08 Month 29 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067363

Disclaimer: Curated by HT Syndication.