Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

This study has been completed.
Sponsor:
Collaborator:
Santa Casa de Misericórdia de Belo Horizonte
Information provided by (Responsible Party):
Renato Santiago Gomez, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01083797
First received: March 8, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during electroencephalography in patients with neurological disorders. The hypothesis is that this drugs provides similar changes in EEG pattern.


Condition Intervention Phase
Other Conditions of Brain
Drug: Dexmedetomidine
Drug: Chloral Hydrate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • electroencephalogram pattern [ Time Frame: twenty minutes ] [ Designated as safety issue: Yes ]

    Qualitative analysis: identification of the deepest phase of sleep achieved during the examination, evaluation of background activity (normal, fast activity increased or slow activity increased).

    Quantitative analysis: density, duration, and amplitude of sleep spindles, spectral power and dominant frequence.



Secondary Outcome Measures:
  • Effective sedative [ Time Frame: twenty minutes ] [ Designated as safety issue: No ]
    Maintain adequate sedation permitting the completion of the examination

  • Adverse effects [ Time Frame: Two hours ] [ Designated as safety issue: Yes ]
    Incidence of bradycardia, hypotension, respiratory complications and vomiting


Enrollment: 25
Study Start Date: December 2009
Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dexmedetomidine, chloral hydrate
sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
Drug: Dexmedetomidine
1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1
Other Name: Dexmedetomidine: Precedex, Abbott Laboratories
Drug: Chloral Hydrate
Initial dose=50 mg/kg
Other Name: Chloral Hydrate 10% solution (100 mg/ml)

Detailed Description:

Patients with chronic neurological disorders such as cerebral palsy or autism need to be sedated during electroencephalography (EEG). However, various sedatives and hypnotics affect the outcome of the review and is not shown. Chloral hydrate (CH) is widely used in children, but in this patients it is less effective.Recently, dexmedetomidine (DEX) has been tested because preliminary data suggests that this drug does not affect the EEG. The aim of the present work was to compare the electroencephalogram (EEG) pattern during CH or DEX sedation, to test the hypothesis that both drugs exert similar effects in EEG.Seventeen patients were evaluated during sedation with DEX or CH on separate occasions.The EEG was subjected to qualitative and quantitative analysis. Clinical variables were also compared.

  Eligibility

Ages Eligible for Study:   12 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neurological disorder
  • behavior disorder
  • epilepsy

Exclusion Criteria:

  • cardiac disease
  • respiratory disease
  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: NCT01083797

Locations
Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Sponsors and Collaborators
Federal University of Minas Gerais
Santa Casa de Misericórdia de Belo Horizonte
Investigators
Principal Investigator: Magda Fernandes Santa Casa de Misericórdia de Belo Horizonte
Study Director: Gomez Renato Federal University of Minas Gerais
  More Information

Publications:
Responsible Party: Renato Santiago Gomez, Magda Lourenço Fernandes, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01083797     History of Changes
Other Study ID Numbers: CEP 106/2009
Study First Received: March 8, 2010
Last Updated: October 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of Minas Gerais:
Sedation
Electroencephalography
Dexmedetomidine
Chloral hydrate

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Chloral Hydrate
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 August 19, 2014