Sedation Clinical Trial
Official title:
Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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