Clinical trial NCT05210764: General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
Official title: General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: General Anesthetic
Electroencephalogram
Keywords: general anesthetic
electroencephalogram
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 366
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital

Brief summary: The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

Detailed description: The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

Eligibility criteria: Inclusion Criteria:

* patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.

Exclusion Criteria:

* Preterm patients;
* Height and weight not within the standard ranges for respective ages;
* Surgery for head or heart;
* Patients with muscular, neurologic or psychiatric diseases;
* Patients with Congenital anomaly or hereditary diseases;
* Patients with medication abuse;
* Allergy to medication including propofol, sevoflurane, and ketamine;
* Allergy to beans;
* Refusal to participate the study by guardians.

Primary outcomes:
measure: phase-amplitude coupling
timeFrame: induction, maintenance, and recovery of anesthesia
measure: bicoherence
timeFrame: induction and maintenance, and recovery of anesthesia
measure: spectral analysis
timeFrame: induction and maintenance, and recovery of anesthesia
measure: entropy indices
timeFrame: induction and maintenance, and recovery of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: STUDY_DIRECTOR
References: