Emergence Agitation, Emergence Delirium, Anesthesia, Preschool Age Children
Conditions
Brief summary
Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Auditory stimulation has been shown to reduce the incidence of ED and postoperative pain during emergence following general anesthesia in children. Therefore, this study aimed to investigate the effects of different types of auditory interventions on the incidence of emergence delirium in children undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia.
Interventions
Repeatedly played Mozart's Lullaby via Bluetooth headphones at 45-60 at 45-60 dB during surgery
OTHERMother's Heartbeat Recording Group
Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery
OTHERMother's Lullaby Recording Group
Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants will be randomly assigned to one of four groups (e.g., by coin toss or lottery draw) with a 1:1:1:1 allocation ratio between the experimental and control groups. Neither participants, caregivers, nor outcome assessors will be aware of the group assignment.
Intervention model description
Classical Music Group M: Mozart's Lullaby played continuously during surgery via Bluetooth headphones at 45-60 decibels; Group H (Mother's Heartbeat Recording): Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery; Group S (Mother's Lullaby Recording): Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery; Control Group C: No intervention.
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Age between 3 and 7 years; * American Society of Anesthesiologists (ASA) physical status classification of I or II; * Pediatric patients scheduled for elective tonsillectomy and/or adenoidectomy under sevoflurane general anesthesia.
Exclusion criteria
* Emergency surgery * The child has developmental delays or neurological disorders, deafness, or hearing impairment * The mother is deaf or absent * The patient and family members declined to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of emergence delirium | Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed. | According to the Pediatric Anesthesia Emergency Delirium Scale (PAED), the occurrence of ED is defined as a PAED score ≥10 at any time during the PACU period (PAED score range: 0-20). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of emergence pain | Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed | 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. |
| Incidence of postoperative adverse events | Perioperative | Including postoperative nausea and vomiting, excessive secretions, laryngospasm, respiratory depression, bradycardia, hypotension |
| PACU Stay Duration | From PACU admission to PACU discharge | — |
Countries
China
Outcome results
None listed