The EEG Study Under Sevoflurane Anesthesia in Children

NCT06580028 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2024-03-217
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Electroencephalography; Sevoflurane; Child Neglect

Keywords

Sevoflurane; Children; Electroencephalogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Modified observer's assessment of alertness#sedation#MOAA/S#scale

  during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)

• Recovery time

  Within up to 30 minutes after operation

• Pediatric anesthesia emergence delirium

  Within up to 30 minutes after operation

• The Face, Legs, Activity, Cry, Consolability Scale (FLACC)

  Within up to 30 minutes after operation

• PHBQ-AS

  3 days after operation

Study Arms (14)

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.

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population met the above inclusion criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yuhang Cai

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu

CONTACT

13957770577; huachengliu@163.com

Yuhang Cai

CONTACT

18815091585; 838097626@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

CN (1)