A prospective clinical trial based on pharmacokinetic/pharmacodynamic modeling of Dexmedetomidine to evaluate its safety and efficacy in children

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001150

Enrollment

Registered

2014-07-03

Start date

2014-09-17

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 ? Low dose group - Loading dose : 0.25mcg/kg intravenous injection for 10 minutes - Maintenance dose : 0.25mcg/kg/hr continuous intravenous infusion following loading dose ? Hi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 2-12 years old ? Scheduled for mechanical ventilation after general anesthesia in the intensive care unit ? Scheduled for extubation within 4 hours postoperatively ? Spontaneous consent from the patient and the guardian after thorough explanation about the study

Exclusion criteria

Exclusion criteria: ? History of drug allergy or allergic reactions ? Cardiovascular disease, cardiac dysfuction, or hypovolemia ? Hypotension or bradycardia ? Hepatic or renal impairment ? Hemodialysis ? Obesity (Body Mass Index over 35) ? Planned for postoperative patient-controlled analgesia using opioids

Design outcomes

Primary

Measure	Time frame
Blood concentration of dexmedetomidine	—

Secondary

Measure	Time frame
Noninvasive blood pressure;Electrocardiogram;Pulse oximetry;Bispectral index;University of Michigan Sedation Scale	—

Countries

Korea, Republic of

Contacts

Public ContactHeesoo Kim

Seoul National University Hospital

heejeong895@gmail.com

Outcome results