Frontal Alpha Asymmetry and Pediatric Emergence Delirium
ConditionEmergence Delirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-8
SponsorGangnam Severance Hospital
About this trial
This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 2-8 year
Children with an American Society of Anesthesiologists (ASA) physical status of I-II
Children who are scheduled to undergo elective ophthalmological requiring general anesthesia
Disqualifiers
Emergency surgery
Patients with developmental delays
Patients with neurological or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances
Patients with autism
Trial population
Children aged 2-8 year with an American Society of Anesthesiologists (ASA) physical status of I-II who are undergoing elective ophthalmological requiring general anesthesia in Gangnam Severance Hospital will be eligible.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ophthalmic surgery
Procedure/SurgeryOphthalmic surgery will be performed as standard practice of our institution.
General anesthesia
Procedure/SurgeryGeneral anesthesia will be performed as standard practice of our institution.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Children with emergence delirium2 interventions
Group B: Children without emergence delirium2 interventions
Trial outcomes
Primary outcomes
1
The peak PAED score
The peak PAED score is the primary outcome variable for mediation analysis
Time frame
After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.Sponsors and contacts
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Source ClinicalTrials.gov