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Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

NCT ID: NCT01083797

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-10-31

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.

Conditions

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Other Conditions of Brain

Keywords

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Sedation Electroencephalography Dexmedetomidine Chloral hydrate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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dexmedetomidine, chloral hydrate

sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients

Group Type OTHER

Dexmedetomidine

Intervention Type DRUG

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

Chloral Hydrate

Intervention Type DRUG

Initial dose=50 mg/kg

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Chloral Hydrate

Initial dose=50 mg/kg

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine: Precedex, Abbott Laboratories Chloral Hydrate 10% solution (100 mg/ml)

Eligibility Criteria

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Inclusion Criteria

* neurological disorder
* behavior disorder
* epilepsy

Exclusion Criteria

* cardiac disease
* respiratory disease
Minimum Eligible Age

12 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santa Casa de Misericórdia de Belo Horizonte

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Renato Santiago Gomez

Magda Lourenço Fernandes

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magda Fernandes

Role: PRINCIPAL_INVESTIGATOR

Santa Casa de Misericórdia de Belo Horizonte

Gomez Renato

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Locations

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Santa Casa de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006.

Reference Type BACKGROUND
PMID: 19589455 (View on PubMed)

Huupponen E, Maksimow A, Lapinlampi P, Sarkela M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Merilainen P, Himanen SL, Jaaskelainen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. doi: 10.1111/j.1399-6576.2007.01537.x. Epub 2007 Nov 14.

Reference Type BACKGROUND
PMID: 18005372 (View on PubMed)

Other Identifiers

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CEP 106/2009

Identifier Type: -

Identifier Source: org_study_id