Clinical Trials Logo
  1. Home
  2. Emergence Delirium
  3. NCT05800639
  4. Details
NCT05800639 Clinical Trial

Frontal Alpha Asymmetry and Pediatric Emergence Delirium

Emergence Delirium Clinical Trial

Official title:
Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05800639
Other study ID # 3-2023-0014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2023
Est. completion date April 20, 2025

Study information
Verified date April 2023
Source Gangnam Severance Hospital
Contact Sun-Kyung Park
Phone 821024505924
Email mayskpark@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date April 20, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 8 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Patients with a recent history (within one month) of receiving general anesthesia - Patients with congenital or genetic diseases that may influence brain development

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ophthalmic surgery
Ophthalmic surgery will be performed as standard practice of our institution.
• General anesthesia
General anesthesia will be performed as standard practice of our institution.

Locations
Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The peak PAED score The peak PAED score is the primary outcome variable for mediation analysis After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.
See also
  Status Clinical Trial Phase
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Completed NCT03788564 - The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Recruiting NCT01221025 - Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain Phase 4
Not yet recruiting NCT06035757 - The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery Phase 4
Not yet recruiting NCT04291820 - Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence N/A
Completed NCT05124067 - Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children Phase 1
Recruiting NCT05091242 - The PREVENT AGITATION Trial II - Children ≤1 Year Phase 2/Phase 3
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Completed NCT04531020 - Incidence of Emergence Delirium in the PACU
Completed NCT05105178 - Verbal Stimulation of Orientation on Emergence Agitation N/A
Completed NCT03285243 - Effect of Monochromatic Light on Incidence of Emergence Delirium in Children N/A
Recruiting NCT04621305 - Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia Phase 4
Completed NCT01096797 - Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children Phase 4
Recruiting NCT03330613 - Emergence Delirium and Recovery Time in Children N/A
Completed NCT05872087 - Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries Phase 1
Recruiting NCT06326983 - Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery N/A
Not yet recruiting NCT06387953 - Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy N/A
Not yet recruiting NCT06406257 - Temperature Management on Postoperative Delirium N/A
Not yet recruiting NCT05883280 - The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery N/A
Not yet recruiting NCT05821972 - Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate Phase 4