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In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration.
The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous dexmedetomidine | Active Comparator | Dexmedetomidine is administered intravenously |
|
| Intranasal administration | Experimental | Dexmedetomidine is administered intranasally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous dexmedetomidine | Drug | 100 ug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute bioavailability of intranasally administered dexmedetomidine | At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h. |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation, local and systemic safety and tolerability of intranasal dexmedetomidine. | At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 5 and 10 h. Only local nasal tolerability is assessed at 5 and 10 h. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timo Iirola, MD | Turku University Hospital | Principal Investigator |
| Klaus T Olkkola, MD, PhD, Professor | Turku University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21318594 | Derived | Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12. |
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| Intranasal dexmedetomidine |
| Drug |
100 ug |
|