Bioavailability, Dexmedetomidine
Conditions
Brief summary
Intranasal dexmedetomidine has been studied and used in children for premedication before anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal Atomization Device (MAD®). Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and bioavailability would be better compares to simple dripping method. To date no pharmacokinetic information of intranasal dexmedetomidine delivered by either method is available. This investigation is designed to compare the bioavailablity of intranasal dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy adults.
Detailed description
This is a three-period crossover double-blinded study. 8 subjects will be recruited and they will attend 3 study sessions after informed written and verbal consent. They would have dexmedetomidine administered via different rout each time, intravenous, intranasal via dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability of each mode of drug delivery.
Interventions
DRUGDexmedetomidine
blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit -
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability of dexmedetomidine | 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| sedation score | 8 hours |
Countries
Hong Kong
Outcome results
None listed