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

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.

Study Overview

• Status: Completed
• Conditions: Children; Emergence Delirium; Anesthesia
• Intervention / Treatment: Device: 40Hz stimulation

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • ZhengZhou, Henan, China, 450000
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Emergency surgery
2. Mental retardation
3. Neurological disorders with manic-like symptoms
4. Presence of severe kidney or liver disease, heart or respiratory disease
5. Autoimmune diseases
6. Vascular malformation of the head and face
7. Significant life changes in the 1 month prior to surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 40Hz stimulation group; At the start of anesthesia, the child received 40Hz transcranial stimulation for 1h.	Device: 40Hz stimulation; 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.
No Intervention: Control group; At the start of anesthesia, the child did not receive any additional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1, day 2, day 3 after surgery.
The incidence of postoperative nausea and vomiting	Follow up patients for nausea and vomiting	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.	Day 1, day 2, day 3 after surgery.

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 6, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: Henan-FSH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No