Dexmedetomidine in Seizure Patients

NCT01116700 | Completed Phase 1

• 1 other identifier: UCSF-AF-02-2010
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seizure Disorders

Keywords

Epilepsy; Dexmedetomidine; Seizure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Patient State Index (PSI) and Entropy

  0-8h

• Visual Analog Scale score

  0-8h

• Ramsay Sedation Score

  0-8h

• Observer's Assessment of Alertness/Sedation Score (OAA/S)

  0-8h

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94122, United States

Location

Related Publications (1)

• 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.

  PMID: 29933272 DERIVED

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

US (1)