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

Electroencephalogram Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210764
• Other study ID #: 2022-01-08
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: March 2024
• Source: Peking University First Hospital
• Contact: Linlin Song, MD
• Phone: 86-13501309217
• Email: songlinlinlynkia[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: August 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electroencephalogram
• General Anesthetic

Intervention

Drug:
• propofol
General anesthesia is induced and maintained mainly with propofol.
• sevoflurane
General anesthesia is induced and maintained mainly with sevoflurane.
• S-ketamine
General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phase-amplitude coupling	phase-amplitude coupling	induction, maintenance, and recovery of anesthesia
Primary	bicoherence	bicoherence	induction and maintenance, and recovery of anesthesia
Primary	spectral analysis	spectral analysis	induction and maintenance, and recovery of anesthesia
Primary	entropy indices	entropy indices	induction and maintenance, and recovery of anesthesia