Anesthesia, Children, Emergence Delirium
Conditions
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.
Interventions
DEVICE40Hz 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.
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| The incidence of postoperative nausea and vomiting | Day 1, day 2, day 3 after surgery. | Follow up patients for nausea and vomiting |
| 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. |
Countries
China
Outcome results
None listed