The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- The incidence of emergence delirium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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).
Eligibility Criteria
- Ages
- 3 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
40Hz stimulation group
At the start of anesthesia, the child received 40Hz transcranial stimulation for 1h.
Intervention: 40Hz stimulation (Device)
Control group
At the start of anesthesia, the child did not receive any additional treatment.
Outcomes
Primary Outcomes
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
- The incidence of pain(Day 1, day 2, day 3 after surgery.)
- Sleep quality(Day 1, day 2, day 3 after surgery.)
- The incidence of postoperative nausea and vomiting(Day 1, day 2, day 3 after surgery.)