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NCT Number: NCT06493513

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

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Key information

Conditions

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

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. The incidence of pain

    Time frame: Day 1, day 2, day 3 after surgery.

    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.

  2. The incidence of postoperative nausea and vomiting

    Time frame: Day 1, day 2, day 3 after surgery.

    Follow up patients for nausea and vomiting

  3. Sleep quality

    Time frame: Day 1, day 2, day 3 after surgery.

    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.

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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