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Dexmedetomidine in Seizure Patients

NCT ID: NCT01116700

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Seizure Disorders

Keywords

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Epilepsy Dexmedetomidine Seizure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alana M Flexman, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Anesthesia

Pekka Talke, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Anesthesia

Paul Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Neurology

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Sleigh JW, Vacas S, Flexman AM, Talke PO. Electroencephalographic Arousal Patterns Under Dexmedetomidine Sedation. Anesth Analg. 2018 Oct;127(4):951-959. doi: 10.1213/ANE.0000000000003590.

Reference Type DERIVED
PMID: 29933272 (View on PubMed)

Other Identifiers

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UCSF-AF-02-2010

Identifier Type: -

Identifier Source: org_study_id