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

Not Applicable

Completed

• Conditions: Emergence Delirium; Anesthesia; Children
• Interventions: Device: 40Hz stimulation

• Registration Number: NCT06493513
• Lead Sponsor: Henan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-06-30
• Study First Submitted QC: 2024-07-06
• Study First Posted: 2024-07-10
• Primary Completion: 2024-08-06
• Study Completion: 2024-08-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The incidence of emergence delirium	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 Outcome Measures

Name	Time	Method
The incidence of postoperative nausea and vomiting	Day 1, day 2, day 3 after surgery.	Follow up patients for nausea and vomiting
The incidence of pain	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.
Sleep quality	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.

Trial Locations

Locations (1)

Henan Provincial People's Hospital; 🇨🇳 ZhengZhou, Henan, China