NCT06698705 The EEG Study Under Remimazolam Anesthesia in Children
| NCT ID | NCT06698705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University |
| Condition | Electroencephalography |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-11-22 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The effect of Remimazolam on brain electrical activity. Previous studies have shown that in healthy male volunteers, EEG changes during Remimazolam infusion are characterized by an initial increase in the beta band and a later increase in the delta band. When monitoring the depth of anesthesia, the commonly used Bispectral Index in clinical practice was originally developed for propofol. Therefore, studies have shown that the correlation between the depth of sedation of benzodiazepines such as midazolam and Bispectral Index is weak. In contrast, the beta wave ratio is considered a more suitable EEG indicator for monitoring the sedative effect of Remimazolam. The above indicates that Remimazolam has a specific pattern of influence on EEG activity, especially in the regulation of anesthesia depth, with unique characteristics.
Eligibility 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. -
Contact & Investigator
Huacheng Liu
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Wenzhou Medical University
Frequently Asked Questions
Who can join the NCT06698705 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 12 Years, studying Electroencephalography. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06698705 currently recruiting?
Yes, NCT06698705 is actively recruiting participants. Contact the research team at huachengliu@163.com for enrollment information.
Where is the NCT06698705 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06698705 clinical trial?
NCT06698705 is sponsored by Second Affiliated Hospital of Wenzhou Medical University. The principal investigator is Huacheng Liu at Second Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 60 participants.