Remimazolam with sevoflurane to reduce wake-up agitation in children after neurosurgery.
The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
This trial will test whether adding a single bolus of remimazolam to sevoflurane anesthesia lowers the chance that children ages 1–6 become agitated as they wake up from neurosurgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT07046364 on ClinicalTrials.gov |
What this trial studies
Children aged 1–6 scheduled for elective neurosurgery lasting more than one hour under sevoflurane anesthesia will be enrolled and receive either a single bolus of remimazolam or a saline placebo in addition to routine anesthetic care. Participants will be followed through recovery to compare the incidence of emergence delirium between the remimazolam and control groups. Standard safety monitoring will be performed during and after anesthesia, and patients with recent sedative use or benzodiazepine allergy will be excluded. The trial builds on prior observations that a remimazolam bolus may reduce postoperative agitation and applies that approach specifically in a pediatric neurosurgery population.
Who should consider this trial
Good fit: Children aged 1–6 years who are scheduled for elective neurosurgery under general anesthesia with an expected duration over one hour and who do not have benzodiazepine allergy are ideal candidates.
Not a fit: Children with benzodiazepine allergy, recent use of other sedatives, ASA class IV or higher, or impairments that prevent emergence delirium assessment are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding remimazolam could reduce how often and how severely children experience agitation when waking up after neurosurgery, making recovery smoother.
How similar studies have performed: A prior study reported that a single remimazolam bolus was associated with a lower incidence of postoperative agitation, providing supportive but not definitive evidence for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 1 to 6 years old * Planned to receive elective neurosurgery under general anesthesia * Expected duration of surgery \> 1 hour Exclusion Criteria: * Allergy to benzodiazepine * Use of other sedatives within 12 hours before surgery such as benzodiazepines, propofol, chloral hydrate, etc., * ASA classification IV or above * Unable to complete emergence delirium assessment, such as language, hearing or vision impairment.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Dong-liang Mu
- Email: mudongliang@bjmu.edu.cn
- Phone: +86 010 83575138
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.