Intensive Care Unit, Postoperative Care
Conditions
Keywords
dexmedetomidine, pediatric, sedation
Brief 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.
Detailed description
Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.
Interventions
DRUGDexmedetomidine Hydrochloride
Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Dexmedetomidine infusion at intensive care unit
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of dexmedetomidine | From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion | Plasma concentration of dexmedetomidine before infusion, 10/30/60 minutes after initiation of infusion, 15/30/60/120/240/480 minutes after end of infusion |
| Bispectral index | From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion | Bispectral index based on electroencephalogram during patient's stay at intensive care unit (0-100, lower score implies deeper sedation) |
| University of Michigan Sedation Scale | From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion | University of Michigan Sedation Scale based on observer's inspection during patient's stay at intensive care unit (0-4, higher score implies deeper sedation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of arrhythmia | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion | Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion |
| Non-invasive blood pressure | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion | Non-invasive blood pressure in units of mmHg, to examine whether hypertension (increase in blood pressure more than 20% of baseline) or hypotension (decrease in blood pressure more than 20% of baseline) occurs |
| Incidence of desaturation | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion | Presence of desaturation (pulse oximetry of lower than 94%) following dexmedetomidine infusion |
| Respiratory rate | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion | Respiratory rate in units of /min, to examine whether respiratory depression or apnea occurs |
| Incidence of nausea | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion | Incidence of nausea following dexmedetomidine infusion |
| Incidence of vomiting | From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion | Incidence of vomiting following dexmedetomidine infusion |
Countries
South Korea
Outcome results
None listed