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

Recruiting

• Conditions: General Anesthetic; Electroencephalogram
• Interventions: Drug: propofol; Drug: S-ketamine; Drug: sevoflurane

• Registration Number: NCT05210764
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Study Start: 2022-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-03-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
propofol	propofol	General anesthesia is induced and maintained mainly with propofol.
ketamine	S-ketamine	General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.
sevoflurane	sevoflurane	General anesthesia is induced and maintained mainly with sevoflurane.

Primary Outcome Measures

Name	Time	Method
phase-amplitude coupling	induction, maintenance, and recovery of anesthesia	phase-amplitude coupling
bicoherence	induction and maintenance, and recovery of anesthesia	bicoherence
spectral analysis	induction and maintenance, and recovery of anesthesia	spectral analysis
entropy indices	induction and maintenance, and recovery of anesthesia	entropy indices

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China