Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

• Status: Completed
• Trial end date: 2019-11-14
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Ministry of Food and Drug Safety, Korea
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery

• Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination

• Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study.

Exclusion Criteria:

• History of hypersensitivity to any drugs including dexmedetomidine.

• Underlying cardiovascular/circulatory disease

• Underlying liver / kidney disease

• Patients under hemodialysis

• Obesity of BMI > 35

• Patients planned to receive patient-controlled analgesia including opioids

• Patients whose parent or legal guardian declined to enroll in the study

• Other conditions deemed unsuitable for the study