Emergence Delirium in Pediatric AnesthesiaNCT07906977
Predicting the Risk of Pediatric Emergence Delirium
An observational study of Emergence Delirium in Pediatric Anesthesia, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The incidence of PED ranges from 2% to 50%, with a peak occurring 5-15 minutes after emergence from anesthesia. PED seriously endangers pediatric patient safety and impairs family experience. Early recognition can guide prophylactic interventions to reduce its incidence. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Emergence Delirium in Pediatric Anesthesia
- What is being tested?
- Assessment of Pediatric Emergence Delirium
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 30 Sep 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- Child
Study population: Eligible children were aged 3 to 12 years, scheduled for elective surgery under general anesthesia with ASA physical status Ⅰ-Ⅱ, and had complete perioperative documentation including preoperative assessment, anesthesia records and PACU PAED scores.
Inclusion Criteria:(1) Aged 3-12 years; (2) Elective surgery under general anesthesia; (3) ASA physical status Ⅰ-Ⅱ; (4) Complete perioperative records (preoperative assessment, anesthesia record, PAED scale score in PACU, etc.).
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Exclusion Criteria:(1) History of severe neuropsychiatric disorders or cognitive impairment; (2) Unavailable data due to anesthesia-related or perioperative complications; (3) Missing key variables or refusal of data utilization; (4) Previous history of pediatric emergence delirium; (5) Other anesthetic complications.
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Trial locations and contacts
1 site in 1 country.
China1 site
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750004
About this study
Official title: Development and Validation of an Interpretable Machine Learning Model for Predicting Pediatric Emergence Delirium
The incidence of PED ranges from 2% to 50%, with a peak occurring 5-15 minutes after emergence from anesthesia. PED seriously endangers pediatric patient safety and impairs family experience. Early recognition can guide prophylactic interventions to reduce its incidence. This study aims to develop machine learning models with high accuracy and interpretability for personalized risk prediction, so as to improve perioperative safety and expand the application of artificial intelligence in pediatric anesthesia, thereby yielding substantial clinical and social benefits.
- Being tested
- Assessment of Pediatric Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Pediatric Emergence DeliriumDiagnostic test
Pediatric emergence delirium will be assessed using the PAED scale at scheduled time points after general anesthesia. The scale evaluation is performed by trained investigators to identify the incidence and severity of emergence delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric emergence delirium
Measured: Emergence delirium typically occurs 15-30 minutes after discontinuation of general anesthesia, with the latest onset up to 45 minutes. Assessment using the PAED scale will be performed at 15, 30 and 45 minutes after anesthesia cessation in PACU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start10 Feb 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
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
- Other
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906977
- Sponsor's protocol ID
- 20260422
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Interpretable Machine Learning Model for Predicting Pediatric Emergence Delirium
- ClinicalTrials.gov ID
- NCT07906977
- Acronym / sponsor ID
- 20260422
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 30 Oct 2026 (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 incidence of PED ranges from 2% to 50%, with a peak occurring 5-15 minutes after emergence from anesthesia. PED seriously endangers pediatric patient safety and impairs family experience. Early recognition can guide prophylactic interventions to reduce its incidence. This study aims to develop machine learning models with high accuracy and interpretability for personalized risk prediction, so as to improve perioperative safety and expand the application of artificial intelligence in pediatric anesthesia, thereby yielding substantial clinical and social benefits.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Eligible children were aged 3 to 12 years, scheduled for elective surgery under general anesthesia with ASA physical status Ⅰ-Ⅱ, and had complete perioperative documentation including preoperative assessment, anesthesia records and PACU PAED scores.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Pediatric Emergence DeliriumPediatric emergence delirium will be assessed using the PAED scale at scheduled time points after general anesthesia. The scale evaluation is performed by trained investigators to identify the incidence and severity of emergence delirium | Diagnostic test | – |
Primary outcome
Pediatric emergence delirium
Time frame: Emergence delirium typically occurs 15-30 minutes after discontinuation of general anesthesia, with the latest onset up to 45 minutes. Assessment using the PAED scale will be performed at 15, 30 and 45 minutes after anesthesia cessation in PACU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 Oct 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pediatric emergence delirium (time frame: Emergence delirium typically occurs 15-30 minutes after discontinuation of general anesthesia, with the latest onset up to 45 minutes. Assessment using the PAED scale will be performed at 15, 30 and 45 minutes after anesthesia cessation in PACU.). 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 30 Oct 2026.