Remimazolam with sevoflurane to reduce wake-up agitation in children after neurosurgery.
Official title: The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
Run by Peking University First Hospital · NCT07046364 · Data updated 2026-11-12
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 |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Enrollment | 248 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT07046364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University First Hospital
Beijing, Beijing Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Dong-liang Mu
- Email: mudongliang@bjmu.edu.cn
- Phone: +86 010 83575138
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Live parent-child video interaction or cartoon watching to ease emergence agitation in preschoolers
This study tests whether live video calls with a parent or watching cartoons during preoperative transfer can reduce anxiety before anesthesia and agitation after surgery in 2- to 6-year-olds undergoing elective procedures.
-
Personalized dosing of remimazolam during general anesthesia using the Eleveld PK/PD model
This trial tests whether a model-guided dosing strategy for remimazolam, tailored to each patient, can improve recovery after general anesthesia in adults undergoing non-cardiac surgery compared with standard dosing.
-
Patient-controlled remimazolam sedation under spinal anesthesia for hip replacement
In adults having hip replacement with spinal anesthesia, this study tests whether letting patients control their own sedation with remimazolam works as well as standard clinician-controlled sedation.
-
Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy
This trial tests whether giving magnesium by mouth before surgery or by IV during surgery can reduce emergence delirium in children aged 4–7 undergoing adenotonsillectomy with sevoflurane anesthesia.
-
Greater auricular nerve block to reduce agitation after children's middle ear surgery
This trial will test whether an ultrasound-guided greater auricular nerve block can reduce agitation and pain when children wake up after microscopic middle ear surgery.
-
Dexmedetomidine–midazolam versus ketamine–midazolam for emergence delirium in children
This test compares dexmedetomidine plus midazolam against ketamine plus midazolam to see which better prevents emergence delirium in children having heart catheterization under general anesthesia.
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.