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Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
Details
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2016-01 |
| Completion | 2018-04 |
Conditions
- Heart Disease
Interventions
- Dexmedetomidine 1mcg/kg Intranasal
- Dexmedetomidine 2mcg/kg Intranasal
- Dexmedetomidine 1mcg Intravenous
Primary outcomes
- Maximum blood concentration level of DEX - Cmax — Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
DEX concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB. - The amount of time that a DEX is present at the maximum concentration - Tmax — Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
DEX concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts (Tmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB. - Area under the curve for DEX concentration levels — Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
DEX concentration will be measured in the blood samples. Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB. - Bioavailability of intranasal DEX relative to intravenous DEX for distribution - plasma concentration — Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring distribution for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX. - Bioavailability of intranasal DEX relative to intravenous DEX for elimination - plasma concentration — Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring elimination for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.
Countries
United States