Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

Phase 3

Completed

• Conditions: Other Conditions of Brain
• Interventions: Drug: Dexmedetomidine; Drug: Chloral Hydrate

• Registration Number: NCT01083797
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2013-03
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• neurological disorder
• behavior disorder
• epilepsy

Exclusion Criteria

• cardiac disease
• respiratory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dexmedetomidine, chloral hydrate	Chloral Hydrate	sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
dexmedetomidine, chloral hydrate	Dexmedetomidine	sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients

Primary Outcome Measures

Name	Time	Method
electroencephalogram pattern	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 Outcome Measures

Name	Time	Method
Effective sedative	twenty minutes	Maintain adequate sedation permitting the completion of the examination
Adverse effects	Two hours	Incidence of bradycardia, hypotension, respiratory complications and vomiting

Trial Locations

Locations (1)

Santa Casa de Belo Horizonte; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil