Clinical trial

General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia

Name

2022-01-08

Description

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.

Trial arms

Trial start

2022-06-01

Estimated PCD

2026-03-01

Trial end

2026-08-01

Status

Recruiting

Treatment

propofol

General anesthesia is induced and maintained mainly with propofol.

Arms:

propofol

Other names:

Propofol anesthesia group

sevoflurane

General anesthesia is induced and maintained mainly with sevoflurane.

Arms:

sevoflurane

Other names:

Sevoflurane anesthesia group

S-ketamine

General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.

Arms:

ketamine

Other names:

S-ketamine anesthesia group

Size

366

Primary endpoint

phase-amplitude coupling

induction, maintenance, and recovery of anesthesia

bicoherence

induction and maintenance, and recovery of anesthesia

spectral analysis

induction and maintenance, and recovery of anesthesia

entropy indices

induction and maintenance, and recovery of anesthesia

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 366, 'type': 'ESTIMATED'}}

Updated at

2024-03-20

1 organization

3 products

2 indications

Organization

Peking University First Hospital

Indication

Indication

Product

Product

Product