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Completed

NCT Number: NCT01083797

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

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.

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Key information

Conditions

Other Conditions of Brain

Age range

12 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Santa Casa de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • neurological disorder
  • behavior disorder
  • epilepsy

Exclusion criteria

  • cardiac disease
  • respiratory disease

Treatment and study plan

Dexmedetomidine

Drug

1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1

Other names: Dexmedetomidine: Precedex, Abbott Laboratories

Chloral Hydrate

Drug

Initial dose=50 mg/kg

Other names: Chloral Hydrate 10% solution (100 mg/ml)

Primary outcomes

  1. electroencephalogram pattern

    Time frame: twenty minutes

    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 outcomes

  1. Effective sedative

    Time frame: twenty minutes

    Maintain adequate sedation permitting the completion of the examination

  2. Adverse effects

    Time frame: Two hours

    Incidence of bradycardia, hypotension, respiratory complications and vomiting

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Santa Casa de Misericórdia de Belo Horizonte

Registry information

Official study title

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 10, 2010
Registry last updated
Oct 25, 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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