Emergence DeliriumNCT06493513
The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium in Children
A study testing 40Hz stimulation in people with Emergence Delirium and Anesthesia, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Emergence Delirium, Anesthesia, Children
- What is being tested?
- 40Hz stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 6 Aug 2024
- Phase
- Interventional
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-14 years old
- ASA classification I or II
- Proposed vascular malformation surgery under sevoflurane general anesthesia
- Anesthesia duration>1h
- Obtaining informed consent
Who cannot join
- Emergency surgery
- Mental retardation
- Neurological disorders with manic-like symptoms
- Presence of severe kidney or liver disease, heart or respiratory disease
- Autoimmune diseases
- Vascular malformation of the head and face
- Significant life changes in the 1 month prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Children
Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to explore the effect of 40Hz stimulation on the incidence of emergence delirium in children undergoing vascular malformation surgery under sevoflurane anesthesia.
- Conditions
- Emergence Delirium, Anesthesia, Children
- Being tested
- 40Hz stimulation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40Hz stimulationDevice
Exogenous 40Hz stimulation is a physical intervention that induces gamma oscillations, oscillations and pulsations at the corresponding frequency, and may lead to a significant reduction in β-amyloid, reversal of tau protein hyperphosphorylation, and consequently improvement of cognitive function in patients.
| Study group | Role | What they receive |
|---|---|---|
| 40Hz stimulation group | Experimental | At the start of anesthesia, the child received 40Hz transcranial stimulation for 1h. Receives: Device: 40Hz stimulation |
| Control group | No intervention | At the start of anesthesia, the child did not receive any additional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence delirium
Emergence delirium was considered to have occurred in the subject child if Pediatric Anesthesia Emergence Delirium (PAED) scale ≥10 or Cornell Assessment of Pediatric Delirium (CAPD) scale ≥10 (PAED range: 0-20 points, CAPD range: 0 ~ 32 points).
Measured: From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.
Secondary outcomes (3)
The incidence of pain
If the Face, Legs, Activity, Cry and Consolability (FLACC) scale ≥ 4 (0 [no pain] ~ 10 [worst pain]), the child was considered to be in pain.
Measured: Day 1, day 2, day 3 after surgery.
The incidence of postoperative nausea and vomiting
Follow up patients for nausea and vomiting
Measured: Day 1, day 2, day 3 after surgery.
Sleep quality
Assessment of children's daily sleep quality by Self-Rating Scale of Sleep (SRSS), with a score range of 10 ~ 50, with higher scores indicating poorer sleep quality.
Measured: Day 1, day 2, day 3 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Apr 2024
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: at the onset of anesthesia, the child received 40Hz transcranial stimulation for 1h. Control group: at the start of anesthesia, the child did not receive any additional treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493513
- Sponsor's protocol ID
- Henan-FSH
- Status last verified
- Oct 2024
- First submitted
- 30 Jun 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu S, Bian J, Fu Y, Yang Y, Wang Y, Zhu G, Ruan X, Li N, Wang D, Zhang J, Sun M. 40-Hz Light Stimulation and Emergence Delirium Incidence After Sevoflurane Anesthesia in Children: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1300-1307. doi: 10.1001/jamapediatrics.2025.3903.
PubMed 41082242
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Children
- ClinicalTrials.gov ID
- NCT06493513
- Acronym / sponsor ID
- Henan-FSH
- Conditions
- Emergence Delirium, Anesthesia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 10 Jul 2024 (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.
Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to explore the effect of 40Hz stimulation on the incidence of emergence delirium in children undergoing vascular malformation surgery under sevoflurane anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: at the onset of anesthesia, the child received 40Hz transcranial stimulation for 1h. Control group: at the start of anesthesia, the child did not receive any additional treatment.
| Arm | Type | Receives |
|---|---|---|
| 40Hz stimulation group | Experimental | Device: 40Hz stimulationAt the start of anesthesia, the child received 40Hz transcranial stimulation for 1h. |
| Control group | No intervention | –At the start of anesthesia, the child did not receive any additional treatment. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 3-14 years old
- ASA classification I or II
- Proposed vascular malformation surgery under sevoflurane general anesthesia
- Anesthesia duration>1h
- Obtaining informed consent
Key exclusion criteria (7 listed)
- Emergency surgery
- Mental retardation
- Neurological disorders with manic-like symptoms
- Presence of severe kidney or liver disease, heart or respiratory disease
- Autoimmune diseases
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 |
|---|---|---|
| 40Hz stimulationExogenous 40Hz stimulation is a physical intervention that induces gamma oscillations, oscillations and pulsations at the corresponding frequency, and may lead to a significant reduction in β-amyloid, reversal of tau protein hyperphosphorylation, and consequently improvement of cognitive function in patients. | Device | 40Hz stimulation group |
Primary outcome
The incidence of emergence delirium
Time frame: From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.
Emergence delirium was considered to have occurred in the subject child if Pediatric Anesthesia Emergence Delirium (PAED) scale ≥10 or Cornell Assessment of Pediatric Delirium (CAPD) scale ≥10 (PAED range: 0-20 points, CAPD range: 0 ~ 32 points).
3 secondary outcomes
The incidence of pain
Time frame: Day 1, day 2, day 3 after surgery.
The incidence of postoperative nausea and vomiting
Time frame: Day 1, day 2, day 3 after surgery.
Sleep quality
Time frame: Day 1, day 2, day 3 after surgery.
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 29 Oct 2024.
- Derived from this study: PubMed 41082242Fu S, Bian J, Fu Y, Yang Y, Wang Y, Zhu G, Ruan X, Li N, Wang D, Zhang J, Sun M. 40-Hz Light Stimulation and Emergence Delirium Incidence After Sevoflurane Anesthesia in Children: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1300-1307. doi: 10.1001/jamapediatrics.2025.3903.
- Individual participant dataSharing planned: No
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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?
A study testing 40Hz stimulation in people with Emergence Delirium and Anesthesia, run by Henan Provincial People's Hospital 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?
The sponsor lists 5 inclusion and 7 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: finished, as of the sponsor's last update on 29 Oct 2024. 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?
The incidence of emergence delirium (time frame: From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06493513, which also lists 1 linked publication.
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 29 Oct 2024.