Dexmedetomidine in Seizure Patients

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01116700

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seizure Disorders	Drug: Dexmedetomidine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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