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RECRUITING
NCT07046364
PHASE4

Remimazolam and Emergence Delirium in Pediatrics

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - 6 Years

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2025-01-01

Completion Date

2027-01-01

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

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.

Locations (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China