Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 2013

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

  • Drug: Dexmedetomidine
    • 1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1
  • Drug: Chloral Hydrate
    • Initial dose=50 mg/kg

Arms, Groups and Cohorts

  • Other: dexmedetomidine, chloral hydrate
    • sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients

Clinical Trial Outcome Measures

Primary Measures

  • electroencephalogram pattern
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • neurological disorder – behavior disorder – epilepsy Exclusion Criteria:

  • cardiac disease – respiratory disease

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Collaborator
    • Santa Casa de Misericórdia de Belo Horizonte
  • Provider of Information About this Clinical Study
    • Principal Investigator: Renato Santiago Gomez, Magda Lourenço Fernandes – Federal University of Minas Gerais
  • Overall Official(s)
    • Magda Fernandes, Principal Investigator, Santa Casa de Misericórdia de Belo Horizonte
    • Gomez Renato, Study Director, Federal University of Minas Gerais

References

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.