Basic data collection for dosing scheme and evaluation of efficacy and safety of dexmedetomidine in children: A clinical trial

Pharmacokinetic and Pharmacodynamic analysis for evaluating the safety and efficacy of dexmedetomidine injection in children and setting the dosage

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0010593

Enrollment

Registered

2025-06-05

Start date

2019-08-14

Completion date

Unknown

Last updated

2025-06-24

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 - Loading dose : 0.5mcg/kg intravenous injection for 10 minutes - Maintenance dose : 0.5mcg/kg/hr continuous intravenous infusion following loading dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 7-18 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+82-2-2072-3659

Outcome results