NCT07249736

"KETOMED: Ketonemia and Risk of Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"

"KETOMED: Ketonemia and Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Hospital Clínico Universitario de Valladolid · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The objective of this observational study is to evaluate the relationship between ketonemia and emergence delirium in children undergoing general anesthesia. The main questions it aims to answer are: * Does the level of ketonemia correlate with the risk of emergence delirium in pediatric patients? * Are there specific perioperative factors that influence this relationship? If there is a comparison group: Not applicable, as this is an observational study without intervention groups. Participants will be asked to: * Provide clinical and demographic information relevant to anesthesia and perioperative care. * Undergo standard perioperative monitoring, including ketonemia measurement. * Allow researchers to record anesthesia and recovery outcomes related to emergence delirium.

Detailed description

KETOMED is a multicenter observational study designed to investigate the relationship between ketonemia and emergence delirium in pediatric patients undergoing general anesthesia. The study will prospectively collect perioperative data from children aged 2 to 12 years who are scheduled for elective procedures under general anesthesia. Blood ketone levels will be measured at standardized time points during the perioperative period, and patients will be monitored for signs of emergence delirium using validated scales (e.g., Pediatric Anesthesia Emergence Delirium scale). In addition to ketonemia, perioperative variables such as type of anesthetic agents, duration of anesthesia, fasting status, and demographic information will be recorded to identify potential confounding factors. The study aims to characterize the incidence of emergence delirium in relation to ketone levels and to explore whether specific metabolic or perioperative conditions are associated with higher risk. No experimental interventions will be applied; all patients will receive standard clinical care. The study is multicenter, allowing collection of data across diverse pediatric populations and surgical procedures, enhancing generalizability.

Conditions

• Emergence Delirium in Pediatric Anesthesia
• Perioperative Ketonemia and Its Association With Recovery Outcomes in Children

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: Spain