Dexmedetomidine in Seizure Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01116700
First received: May 3, 2010
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Seizure Disorders
Drug: Dexmedetomidine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Serum level of dexmedetomidine [ Time Frame: 0-8 hour period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-8h ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-8h ] [ Designated as safety issue: No ]
    VAS scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.

  • Ramsay Sedation Score [ Time Frame: 0-8h ] [ Designated as safety issue: No ]
    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) [ Time Frame: 0-8h ] [ Designated as safety issue: No ]
    OAA/S scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.


Enrollment: 16
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexmedetomidine
    Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
    Other Name: Precedex
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116700

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94122
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Alana M Flexman, MD UCSF Department of Anesthesia
Principal Investigator: Pekka Talke, MD UCSF Department of Anesthesia
Principal Investigator: Paul Garcia, MD UCSF Department of Neurology
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01116700     History of Changes
Other Study ID Numbers: UCSF-AF-02-2010
Study First Received: May 3, 2010
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Epilepsy
Dexmedetomidine
Seizure

Additional relevant MeSH terms:
Seizures
Disease
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014