Emergence Delirium in Pediatric AnesthesiaKETOMEDNCT07249736
"KETOMED: Ketonemia and Risk of Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"
An observational study of Emergence Delirium in Pediatric Anesthesia and Perioperative Ketonemia and Its Association With Recovery Outcomes in Children, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium in Pediatric Anesthesia, Perioperative Ketonemia and Its Association With Recovery Outcomes in Children
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Age between 2 and 12 years
- Elective procedure under general anesthesia
- Inpatient or Ambulatory Surgery Center (ASC) setting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47010
About this study
Official title: "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?
Read more
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.
Read the 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
- Keywords
- Pediatric anesthesia, Emergence delirium, Ketonemia, Perioperative monitoring, Multicenter observational study
- Medical subject headings
- Emergence Delirium, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the immediate postoperative recovery period (typically 30-60 minutes after emergence from anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start2 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium in Pediatric AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Lopez Santin, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249736
- Sponsor's protocol ID
- Unique Protocol ID: PI-GR-25-4
- Acronym
- KETOMED
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "KETOMED: Ketonemia and Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"
- ClinicalTrials.gov ID
- NCT07249736
- Acronym / sponsor ID
- KETOMED / Unique Protocol ID: PI-GR-25-4
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Age between 2 and 12 years
- Elective procedure under general anesthesia
- Inpatient or Ambulatory Surgery Center (ASC) setting
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium in Pediatric Anesthesia and Perioperative Ketonemia and Its Association With Recovery Outcomes in Children, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Emergence Delirium in Pediatric Patients (time frame: During the immediate postoperative recovery period (typically 30-60 minutes after emergence from anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.