Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

Other Conditions of Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083797
• Other study ID #: CEP 106/2009
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2010
• Last updated: October 24, 2013
• Start date: December 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 38 Years

Eligibility

Inclusion Criteria:

• neurological disorder

• behavior disorder

• epilepsy

Exclusion Criteria:

• cardiac disease

• respiratory disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Other Conditions of Brain

Intervention

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

Locations

Country	Name	City	State
Brazil	Santa Casa de Belo Horizonte	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Santa Casa de Misericórdia de Belo Horizonte

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Huupponen E, Maksimow A, Lapinlampi P, Särkelä M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Meriläinen P, Himanen SL, Jääskeläinen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. Epub 2007 Nov 14. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electroencephalogram pattern	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.	twenty minutes	Yes
Secondary	Effective sedative	Maintain adequate sedation permitting the completion of the examination	twenty minutes	No
Secondary	Adverse effects	Incidence of bradycardia, hypotension, respiratory complications and vomiting	Two hours	Yes