Observing brain activity in children under sevoflurane anesthesia
Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study
This study looks at how sevoflurane anesthesia affects brain activity in young children aged 0 to 6 years to better understand its impact on their developing brains.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 1 Day to 6 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06580028 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the electroencephalogram (EEG) characteristics of children aged 0 to 6 years while under sevoflurane general anesthesia. Children will be divided into 14 age groups, with 20 participants in each group, to analyze the time-frequency characteristics of their prefrontal EEG. The study seeks to enhance understanding of how sevoflurane affects brain activity across different developmental stages. Informed consent will be obtained from parents or legal guardians before participation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 day to 6 years who require general anesthesia with sevoflurane and have a physical status classified as ASA I or II.
Not a fit: Patients with congenital malformations, severe health conditions, or recent upper respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and efficacy of anesthesia in young children by providing insights into their brain activity during procedures.
How similar studies have performed: While there have been studies on EEG under anesthesia, this specific approach focusing on sevoflurane in young children is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wenzhou, Zhejiang
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Huacheng Liu — Second Affiliated Hospital of Wenzhou Medical University
- Study coordinator: Huacheng Liu
- Email: huachengliu@163.com
- Phone: 13957770577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.