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Completed

NCT Number: NCT01116700

Dexmedetomidine in Seizure Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Francisco

San Francisco, California, 94122, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 5, 2010
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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