RecruitingPhase 4NCT07046364

Remimazolam and Emergence Delirium in Pediatrics

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


Sponsor

Peking University First Hospital

Enrollment

248 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 6 Years

Inclusion Criteria3

  • Aged 1 to 6 years old
  • Planned to receive elective neurosurgery under general anesthesia
  • Expected duration of surgery \> 1 hour

Exclusion Criteria4

  • 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.

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Interventions

DRUGRemimazolam

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.

DRUGNormal 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

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NCT07046364


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