Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01083797

Enrollment

Registered

2010-03-10

Start date

2009-12-31

Completion date

2013-10-31

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Conditions of Brain

Keywords

Sedation, Electroencephalography, Dexmedetomidine, Chloral hydrate

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.

Interventions

DRUGDexmedetomidine

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

DRUGChloral Hydrate

Initial dose=50 mg/kg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 38 Years

Healthy volunteers

Inclusion criteria

* neurological disorder * behavior disorder * epilepsy

Exclusion criteria

* cardiac disease * respiratory disease

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026