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

Z

Zhengzhou University

Status

Completed

Conditions

Emergence Delirium
Children
Anesthesia

Treatments

Device: 40Hz stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06493513
Henan-FSH

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

3 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jiaqiang Zhang, Ph.D

Data sourced from clinicaltrials.gov

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