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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-08-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Emergence Delirium Anesthesia Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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).

Study Groups

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40Hz stimulation group

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

Group Type EXPERIMENTAL

40Hz stimulation

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No