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

NCT ID: NCT07249736

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2027-05-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Eva Lopez Santin

Investigator, Pediatric Anesthesia Department, Hospital Clínico Universitario de Valladolid

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Countries

Spain

Other Identifiers

Unique Protocol ID: PI-GR-25-4

Identifier Type: -

Identifier Source: org_study_id