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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergence Delirium in Pediatric Anesthesia; Perioperative Ketonemia and Its Association With Recovery Outcomes in Children

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Valladolid
    • Valladolid, Valladolid, Spain, 47010
      • Hospital Clínico Universitario de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospital Clínico Universitario de Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Emergence delirium; Pediatric anesthesia; Perioperative monitoring; Ketonemia; Multicenter observational study
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Metabolic Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Acid-Base Imbalance; Acidosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Emergence Delirium; Ketosis
• Other Study ID Numbers: Unique Protocol ID: PI-GR-25-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No