Effects of Remimazolam on Brain Activity in Children
Official title: Electroencephalogram Study in Children Under Remimazolam Anesthesia - a Prospective,Observational Study
Run by Second Affiliated Hospital of Wenzhou Medical University · NCT06698705 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Year to 12 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Status | Recruiting |
| Started | November 22, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | February 6, 2025 |
| Trial ID | NCT06698705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with congenital malformations, severe medical conditions, or recent upper respiratory infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anesthesia monitoring in children.
How similar studies have gone: Previous studies have indicated specific EEG patterns during Remimazolam anesthesia in adults, suggesting potential for success in this pediatric population.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.