The external validation of Dexmedetomidine model in children

The external validation of pharmacokinetic-pharmacodynamic model of Dexmedetomidine for target-controlled infusion in children

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001665

Enrollment

Registered

2015-10-16

Start date

2015-11-30

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Dexmedetomidine Target effect site concentration 0.2, 0.4, 0.6 ng/ml Intravenous injection Blood sampling three times

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 2-12 years old ? Mechanical ventilation in intensive care unit ? Spontaneously agreed to participate in the study by the patients and legal guardians or parents

Exclusion criteria

Exclusion criteria: ? History of allergy or anaphylaxis to drug ? Under patient-controlled analgesia with opioids ? Cardiovascular disease or circulatory collapse ? Hypotension or bradycardia ? Liver or kidney disease ? Hemodialysis ? Body mass index over 35 ? Judged noncompatible by the investigator

Design outcomes

Secondary

Measure	Time frame
Blood pressure;Heart rate;Pulse oximetry;Bispectral Index;University of Michigan Sedation Scale	—

Primary

Measure	Time frame
Blood concentration	—

Countries

Korea, Republic of

Contacts

Public ContactHee-Soo Kim

Seoul National University Hospital

heejeong895@gmail.com

Outcome results