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Remimazolam and Emergence Delirium in Pediatrics

NCT07046364 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-07-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046364 on ClinicalTrials.gov