Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 25, 2013
October 1, 2013
3.2 years
March 8, 2010
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Effective sedative
twenty minutes
Adverse effects
Two hours
Study Arms (1)
dexmedetomidine, chloral hydrate
OTHERsedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
Interventions
1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1
Initial dose=50 mg/kg
Eligibility Criteria
You may qualify if:
- neurological disorder
- behavior disorder
- epilepsy
You may not qualify if:
- cardiac disease
- respiratory disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Related Publications (2)
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: 19589455BACKGROUNDHuupponen 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: 18005372BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magda Fernandes
Santa Casa de Misericórdia de Belo Horizonte
- STUDY DIRECTOR
Gomez Renato
Federal University of Minas Gerais
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Magda Lourenço Fernandes
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 10, 2010
Study Start
December 1, 2009
Primary Completion
March 1, 2013
Study Completion
October 1, 2013
Last Updated
October 25, 2013
Record last verified: 2013-10