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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40Hz stimulation group | Experimental | At the start of anesthesia, the child received 40Hz transcranial stimulation for 1h. |
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| Control group | No Intervention | At the start of anesthesia, the child did not receive any additional treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergence delirium | 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). | From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of pain | 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. | Day 1, day 2, day 3 after surgery. |
| The incidence of postoperative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41082242 | Derived | Fu S, Bian J, Fu Y, Yang Y, Wang Y, Zhu G, Ruan X, Li N, Wang D, Zhang J, Sun M. 40-Hz Light Stimulation and Emergence Delirium Incidence After Sevoflurane Anesthesia in Children: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1300-1307. doi: 10.1001/jamapediatrics.2025.3903. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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.
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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).
|
Follow up patients for nausea and vomiting |
| Day 1, day 2, day 3 after surgery. |
| Sleep quality | 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. | Day 1, day 2, day 3 after surgery. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |