Dexmedetomidine in Seizure Patients

Seizure Disorders Clinical Trial

Official title:

The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116700
• Other study ID #: UCSF-AF-02-2010
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2010
• Last updated: August 6, 2013
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Epilepsy
• Seizure Disorders
• Seizures

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of dexmedetomidine	Serum levels of dexmedetomidine will be taken at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.	0-8 hour period	No
Secondary	Patient State Index (PSI) and Entropy	PSI and/or state entropy will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.	0-8h	No
Secondary	Visual Analog Scale score	VAS scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.	0-8h	No
Secondary	Ramsay Sedation Score	Ramsay sedation scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.	0-8h	No
Secondary	Observer's Assessment of Alertness/Sedation Score (OAA/S)	OAA/S scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.	0-8h	No