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

NCT07249736 | Active Not Recruiting

• 1 other identifier: Unique Protocol ID: PI-GR-25-4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pediatric anesthesia; Emergence delirium; Ketonemia; Perioperative monitoring; Multicenter observational study

Outcome Measures

Primary Outcomes (1)

• Incidence of Emergence Delirium in Pediatric Patients

  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).

  During the immediate postoperative recovery period (typically 30-60 minutes after emergence from anesthesia)

Study Arms (1)

Pediatric Anesthesia Cohort

This cohort includes children undergoing elective general anesthesia at participating centers. Participants will receive standard clinical care without experimental interventions. Blood samples will be collected perioperatively to measure ketone levels, and emergence delirium will be monitored using validated scales. Clinical and demographic data will also be recorded to explore potential risk factors associated with emergence delirium.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes children aged 2 to 12 years undergoing elective procedures under general anesthesia at participating centers. Participants may be admitted as inpatients or treated in an Ambulatory Surgery Center (ASC). Children with neuropsychiatric disorders, carbohydrate metabolism disorders, those undergoing emergency surgery, or requiring postoperative admission to the Pediatric Intensive Care Unit (PICU) are excluded.

You may qualify if:

• Age between 2 and 12 years
• Elective procedure under general anesthesia
• Inpatient or Ambulatory Surgery Center (ASC) setting

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47010, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for ketone measurement (serum or whole blood) collected perioperatively. Samples will be stored temporarily for ketone analysis and then discarded according to standard laboratory procedures.

MeSH Terms

Conditions

Emergence Delirium; Ketosis

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Pediatric Anesthesia Department, Hospital Clínico Universitario de Valladolid

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-10

Locations

ES (1)