Seizure Disorders
Conditions
Keywords
Epilepsy, Dexmedetomidine, Seizure
Brief summary
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-65, BMI 20-25 kg/m2 * Anticonvulsant Group: Diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks * Control Group: Healthy volunteers taking no medications
Exclusion criteria
* Positive urine pregnancy test or lactating * History of allergy to dexmedetomidine or alpha -2 agonists * History of liver, renal or thyroid disease * History of cardiovascular disease including history of arrhythmia or congestive heart failure * History of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of dexmedetomidine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient State Index (PSI) and Entropy | 0-8h | PSI and/or state entropy will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine. |
| Visual Analog Scale score | 0-8h | VAS scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine. |
| Ramsay Sedation Score | 0-8h | Ramsay sedation scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine. |
| Observer's Assessment of Alertness/Sedation Score (OAA/S) | 0-8h | OAA/S scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine. |
Countries
United States
Outcome results
None listed