Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

NCT01083797 — Phase 3, Completed, 25 participants, Federal University of Minas Gerais

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

Registry	NCT01083797
Status	Completed
Phase	Phase 3
Study type	Interventional; na, single group, masking: single, treatment
Enrollment	25 (Actual)
Sponsor	Federal University of Minas Gerais (Other); collaborators: Santa Casa de Misericórdia de Belo Horizonte
Conditions	Other Conditions of Brain
Interventions	Dexmedetomidine, Chloral Hydrate (Drug)
Dates	start 2009-12-01, primary completion 2013-03-01, completion 2013-10-01, first posted 2010-03-10, last updated 2013-10-25
Locations	1 site in Brazil

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
dexmedetomidine, chloral hydrate	Other	Drug: Dexmedetomidine; Drug: Chloral Hydrate	sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients

Dexmedetomidine (Drug), also known as Dexmedetomidine: Precedex, Abbott Laboratories: 1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1
Chloral Hydrate (Drug), also known as Chloral Hydrate 10% solution (100 mg/ml): Initial dose=50 mg/kg

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 12 Years to 38 Years

Inclusion Criteria:

* neurological disorder
* behavior disorder
* epilepsy

Exclusion Criteria:

* cardiac disease
* respiratory disease

+Locations (1)

Facility	City	Country	Status
Santa Casa de Belo Horizonte	Belo Horizonte, Minas Gerais	Brazil

+Publications

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. PMID 19589455
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. PMID 18005372

+Investigators

Magda Fernandes, Principal investigator, Santa Casa de Misericórdia de Belo Horizonte
Gomez Renato, Study director, Federal University of Minas Gerais

My Notes

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