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NCT Number: NCT07249736

"KETOMED: Ketonemia and Risk of 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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Emergence Delirium in Pediatric Patients

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospital Clínico Universitario de Valladolid

Other

Registry information

Official study title

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

Acronym: KETOMED

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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