The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium in Children

NCT06493513 | Completed

• 1 other identifier: Henan-FSH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.

Secondary Outcomes (3)

• The incidence of pain

  Day 1, day 2, day 3 after surgery.

• The incidence of postoperative nausea and vomiting

  Day 1, day 2, day 3 after surgery.

• Sleep quality

  Day 1, day 2, day 3 after surgery.

Study Arms (2)

40Hz stimulation group

EXPERIMENTAL

At the start of anesthesia, the child received 40Hz transcranial stimulation for 1h.

Device: 40Hz stimulation

Control group

NO INTERVENTION

At the start of anesthesia, the child did not receive any additional treatment.

Interventions

40Hz stimulation DEVICE

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.

40Hz stimulation group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-14 years old
• ASA classification I or II
• Proposed vascular malformation surgery under sevoflurane general anesthesia
• Anesthesia duration\>1h
• Obtaining informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• 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.

  PMID: 41082242 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized (like flipping a coin or drawing from a hat) to either of the two groups, with the probability of a participant being in the experimental and control groups being 1:1. and neither participant, nor care Provider, nor the outcome assessor, nor the investigator will know to which group participant has been assigned (or add 40 Hz transcranial stimulation).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 10, 2024
• Study Start: April 1, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)