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.
Other Conditions of Brain
Drug: Chloral Hydrate
|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|
- 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.
- 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
|Study Start Date:||December 2009|
|Study Completion Date:||October 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
dexmedetomidine, chloral hydrate
sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
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 LaboratoriesDrug: Chloral Hydrate
Initial dose=50 mg/kg
Other Name: Chloral Hydrate 10% solution (100 mg/ml)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083797
|Santa Casa de Belo Horizonte|
|Belo Horizonte, Minas Gerais, Brazil, 30150-221|
|Principal Investigator:||Magda Fernandes||Santa Casa de Misericórdia de Belo Horizonte|
|Study Director:||Gomez Renato||Federal University of Minas Gerais|