Dexmedetomidine in Seizure Patients

August 6, 2013 updated by: University of California, San Francisco

The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94122
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of dexmedetomidine
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.
0-8 hour period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient State Index (PSI) and Entropy
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.
0-8h
Visual Analog Scale score
Time Frame: 0-8h
VAS scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
0-8h
Ramsay Sedation Score
Time Frame: 0-8h
Ramsay sedation scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
0-8h
Observer's Assessment of Alertness/Sedation Score (OAA/S)
Time Frame: 0-8h
OAA/S scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
0-8h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (ESTIMATE)

May 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSF-AF-02-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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