Heart Diseases
Conditions
Keywords
Pediatric, Sedation, Dexmedetomidine
Brief summary
This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
Detailed description
The study will be a prospective study of plasma concentrations after intranasal or buccal DEX to determine the early pharmacokinetics and bioavailability of a single dose via nasal or oral administration. Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other pediatric institutions. This compound is typically delivered intravenously or intranasally for sedation in children with or without congenital heart disease. Intranasal DEX is very effective for sedation although it has significant variability in the onset and peak effect. Patient care will be improved if factors that determine this variability can be determined. Investigators will determine the important clinical variables of peak plasma DEX concentration (Tmax and Cmax) of intranasal and buccal DEX in children.
Interventions
DRUGDexmedetomidine buccal
DEX 2 mcg/kg buccal
DRUGDexmedetomidine Intranasal
DEX 3 mcg/kg intranasal
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 48 Months
Healthy volunteers
No
Inclusion criteria
* Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery * The subject must be a candidate to receive Dex as determined by one of the study cardiac anesthesiologists * The attending cardiac anesthesiologists for the case and the Chief of Anesthesia Cardiac Anesthesia will concur with or veto this decision * The subjects legally authorized representative has given written informed consent to participate in the study
Exclusion criteria
* Post-natal age less than 6 months * The subject is allergic to or has had a contraindication to Dex * Severely depressed ventricular function on preoperative echocardiogram * The subject has a high risk of cardiac conduction system disease in the judgement of the attending anesthesiologist or cardiologist * The subject has a hemodynamically significant aortic coarctation or other left heart outflow obstruction * The subject has received digoxin, beta-adrenergic antagonist, or calcium channel antagonist on the day of surgery * The subject has received Dex within 1 week of the study date * Patients who are to receive intranasal Dex are excluded if they have nasal/respiratory symptoms, which in the opinion of the study anesthesiologist, may affect intranasal drug absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum blood concentration level of Dex - Cmax | Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . | Dex concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax). |
| The amount of time that Dex is present at the maximum concentration - Tmax | Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . | Dex concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability of IN Dex relative to intravenous Dex for elimination - plasma concentration. | Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . | Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators will be measuring for approximately one half-life of Dex. This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex. |
| Area under the curve for Dex concentration levels | Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . | Dex concentration will be measured in the blood samples. |
| Systolic and diastolic blood pressure with Dex administration | Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours. | Systolic and diastolic blood pressure will be recorded by clinical staff prior to the procedure and continuously during the procedure. The systolic and diastolic blood pressure during the time of study blood collection will be compared to the baseline blood pressure to determine is any adverse events occurred. |
| Adverse events associated with Dex administration | Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours. | Heart rate will be recorded by clinical staff prior to the procedure and continuously during the procedure. The heart rate during the time of study blood collection will be compared to the baseline vitals to determine is any adverse events occurred. |
| Bioavailability of intranasal Dex relative to intravenous Dex for distribution - plasma concentration | Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been . | Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators will be measuring for approximately one half-life of Dex. This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex. |
Countries
United States
Outcome results
None listed