NCT07046364 Remimazolam and Emergence Delirium in Pediatrics
| NCT ID | NCT07046364 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Pediatric |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 248 participants in total. It began in 2025-01-01 with a primary completion date of 2027-01-01.
⚠ 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
Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07046364 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 6 Years, studying Pediatric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07046364 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07046364 currently recruiting?
Yes, NCT07046364 is actively recruiting participants. Contact the research team at mudongliang@bjmu.edu.cn for enrollment information.
Where is the NCT07046364 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07046364 clinical trial?
NCT07046364 is sponsored by Peking University First Hospital. The trial plans to enroll 248 participants.