The EEG Study Under Sevoflurane Anesthesia in Children

Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study

Sevoflurane is one of the most commonly used volatile anesthetics in children because of its rapid induction, recovery and recovery properties. Clinical studies using noninvasive brain monitoring have shown that general anesthetics and hypnotics generate electroencephalogram (EEG) oscillations in specific spatial tissues that are fundamentally related to the structure and function of neural circuits. Slow-wave-delta (0.1-4 Hz) oscillations were present in children of all ages, and the advantage of frontal α-wave oscillations appeared at approximately 6 months, began to be consistent at 10 months, and persisted at older ages. Another study, which analyzed EEG under sevoflurane general anesthesia in children aged 0-6 months, found that Theta and alpha wave power decreased with a decrease in sevoflurane concentrations in infants between 4 and 6 months of recovery. However, these studies lack detailed characterization of the neural circuit activity associated with anesthesia, especially at specific developmental ages that are highly correlated with brain plasticity. The aim of this study was to explore electroencephalogram (EEG) of children of different ages under sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) . By analyzing these EEG data in detail, we hope to be able to better understand the EEG characteristics of children of different ages under sevoflurane anesthesia, and thus develop a neurophysiology pediatric anesthesia status monitoring strategy.

Study Overview

• Status: Recruiting
• Conditions: Sevoflurane; Electroencephalography; Child Neglect

Detailed Description

This study is prospective and observational. Children under sevoflurane general anesthesia were divided into 14 groups (0-3 months old, 3-6 months old, 6-9 months old, 9-12 months old, 1-1.5 years old, 1.5-2 years old, 2-2.5 years old, 2.5-3 years old, 3-3.5 years old, 3.5-4 years old, 4-4.5 years old, 4.5.5 years old, 5.5.5 years old, 5.5-6 years old) , there were 20 cases in each group. Inform the family about the research plan and obtain informed consent. To observe the time-frequency characteristics of prefrontal electroencephalogram (EEG) in children of different ages under general anesthesia with sevoflurane.

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Yuhang Cai; Phone Number: 18815091585; Email: 838097626@qq.com
• Study Contact Backup: Name: Huacheng Liu; Phone Number: 13957770577; Email: huachengliu@163.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
      • Contact: Yuhang Cai; Phone Number: 18815091585; Email: 838097626@qq.com
      • Contact: Huacheng Liu; Phone Number: 13957770577; Email: huachengliu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population met the above inclusion criteria.

Description

Inclusion Criteria:

1. aged 1 days#6 years#;
2. with American Society of Anesthesiologists (ASA) physical status I or II#;
3. children requiring general anesthesia under sevoflurane;
4. parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

Exclusion Criteria:

1. Congenital malformation or other genetic conditions that are thought to affect brain development ;
2. History of severe heart, brain, liver, kidney and metabolic diseases ;
3. Premature infants (≤32 weeks);
4. Upper respiratory tract infection in the last two weeks.

Study Plan

How is the study designed?

Number of groups / cohorts

14

Cohorts and Interventions

Group / Cohort
0-3 months; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3-6 months; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
6-9 months; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
9-12 months; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
1-1.5 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
1.5-2 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
2-2.5 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
2.5-3 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3-3.5 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
3.5-4 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
4-4.5 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
4.5-5 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
5-5.5 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.
5.5-6 years; EEG was collected during the whole perioperative period, including preoperative conscious period (or preoperative sedation period) , anesthesia period and anesthesia recovery period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-frequency characteristics of electroencephalogram (EEG)	Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) .	during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHBQ-AS	Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) is a parental report measure used to assess negative behavior change after hospitalization, consisting of 11 items on 1-5 score. The PHBQ-AS score will be calculated for each respondent as the mean score of all individual items answered on the questionnaire. A score above 3 will indicate the presence of negative behavioral change, a score equal to 3 will indicate no behavioral change, and a score below 3 will indicate an improvement in behavior.	3 days after operation
Modified observer's assessment of alertness#sedation#MOAA/S#scale	5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking; 1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation	during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)
Recovery time	From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9	Within up to 30 minutes after operation
Pediatric anesthesia emergence delirium	The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.	Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)	The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.	Within up to 30 minutes after operation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Huacheng Liu, Second Affiliated Hospital of Wenzhou Medical University; Principal Investigator: Yuhang Cai, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Children; Electroencephalogram; Sevoflurane
• Other Study ID Numbers: SAHoWMU-CR2024-03-217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No