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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05210764
Other study ID # 2022-01-08
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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