Effects of Remimazolam on Brain Activity in Children
Electroencephalogram Study in Children Under Remimazolam Anesthesia - a Prospective,Observational Study
Second Affiliated Hospital of Wenzhou Medical University · NCT06698705
This study looks at how a type of anesthesia called Remimazolam affects brain activity in children aged 1 to 12 years during surgery to help improve safety and monitoring.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 12 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University (other) |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06698705 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how Remimazolam anesthesia affects brain electrical activity in children aged 1 to 12 years. Participants will be grouped by age and monitored for changes in electroencephalography (EEG) during anesthesia induction, maintenance, and recovery. The study aims to identify specific EEG patterns associated with Remimazolam, which may improve monitoring techniques for anesthesia depth in pediatric patients. Informed consent will be obtained from parents or legal guardians prior to participation.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 12 years requiring general anesthesia with Remimazolam and classified as ASA physical status I or II.
Not a fit: Patients with congenital malformations, severe medical conditions, or recent upper respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anesthesia monitoring in children.
How similar studies have performed: Previous studies have indicated specific EEG patterns during Remimazolam anesthesia in adults, suggesting potential for success in this pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. aged 1 years-12 years; 2, with American Society of Anesthesiologists (ASA) physical status I or II; 3, children requiring general anesthesia under remimazolam; 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.
Conditions: Electroencephalography, Remimazolam, Child Neglect, children