"KETOMED: Ketonemia and Risk of Emergence Delirium in Children Undergoing General Anesthesia - A … (NCT07249736) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
"KETOMED: Ketonemia and Risk of Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"
Spain200 participantsStarted 2025-06-02
Plain-language 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.
Who can participate
Age range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Emergence Delirium in Pediatric Patients
Timeframe: During the immediate postoperative recovery period (typically 30-60 minutes after emergence from anesthesia)
Trial details
NCT IDNCT07249736
SponsorHospital Clínico Universitario de Valladolid