NCT07046364

Remimazolam and Emergence Delirium in Pediatrics

The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric
• Neurosurgery
• Sevoflurane Anesthesia
• Remimazolam
• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Remimazolam	After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of remimazolam), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of remimazolam). The infusion is expected to stop 10 minutes before the end of the surgery.
DRUG	Normal Saline	After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of normal saline), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of normal saline). The infusion is expected to stop 10 minutes before the end of the surgery.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

2 sites across 1 country: China