University of California San Francisco
San Francisco, California, 94122, United States
NCT Number: NCT01116700
Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. The investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
San Francisco, California, 94122, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
Other names: Precedex
Time frame: 0-8 hour period
Serum levels of dexmedetomidine will be taken at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Time frame: 0-8h
PSI and/or state entropy will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Time frame: 0-8h
VAS scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Time frame: 0-8h
Ramsay sedation scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Time frame: 0-8h
OAA/S scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
University of California, San Francisco
Other
The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders
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