A prospective clinical trial based on pharmacokinetic/pharmacodynamic modeling of Dexmedetomidine to evaluate its safety and efficacy in childre
Not Applicable
Completed
- Conditions
- Not Applicable
- Registration Number
- KCT0001150
- Lead Sponsor
- Seoul National University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
? 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood concentration of dexmedetomidine
- Secondary Outcome Measures
Name Time Method oninvasive blood pressure;Electrocardiogram;Pulse oximetry;Bispectral index;University of Michigan Sedation Scale