Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Other Conditions of Brain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Chloral Hydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neurological disorder behavior disorder epilepsy Exclusion Criteria: cardiac disease respiratory disease

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dexmedetomidine, chloral hydrate<br>sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients | Drug: Dexmedetomidine<br>* 1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1<br>* Other names: Dexmedetomidine: Precedex, Abbott Laboratories;Drug: Chloral Hydrate<br>* Initial dose=50 mg/kg<br>* Other names: Chloral Hydrate 10% solution (100 mg/ml);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroencephalogram pattern | 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. | twenty minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective sedative | Maintain adequate sedation permitting the completion of the examination | twenty minutes | 
| Adverse effects | Incidence of bradycardia, hypotension, respiratory complications and vomiting | Two hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Electroencephalography, Dexmedetomidine, Chloral hydrate