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Clinical Trials in Spain / NCT07249736
Active, not recruiting Observational

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

NCT07249736 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Clínico Universitario de Valladolid
Phase
Observational
Started
2025-06-02
Last updated
2025-11-25

Condition(s) studied

Emergence Delirium in Pediatric AnesthesiaPerioperative Ketonemia and Its Association With Recovery Outcomes in Children

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age between 2 and 12 years * Elective procedure under general anesthesia * Inpatient or Ambulatory Surgery Center (ASC) setting Exclusion Criteria: * Age younger than 2 years or older than 12 years * Emergency surgery * Postoperative admission to the Pediatric Intensive Care Unit (PICU) * Neuropsychiatric disorder * Carbohydrate metabolism disorder * Declines to participate voluntarily in the study

Primary outcome measure(s)

  • Incidence of Emergence Delirium in Pediatric Patients — During the immediate postoperative recovery period (typically 30-60 minutes after emergence from anesthesia)
    The proportion of children experiencing emergence delirium during the recovery period after general anesthesia, assessed using a validated scale (e.g., Pediatric Anesthesia Emergence Delirium scale).

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario de Valladolid Valladolid Valladolid

More Hospital Clínico Universitario de Valladolid trials in Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07249736 on ClinicalTrials.gov ↗ ← All trials in Spain