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Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

Primary Purpose

Other Conditions of Brain

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dexmedetomidine
Chloral Hydrate
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Other Conditions of Brain focused on measuring Sedation, Electroencephalography, Dexmedetomidine, Chloral hydrate

Eligibility Criteria

12 Years - 38 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • neurological disorder
  • behavior disorder
  • epilepsy

Exclusion Criteria:

  • cardiac disease
  • respiratory disease

Sites / Locations

  • Santa Casa de Belo Horizonte

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

dexmedetomidine, chloral hydrate

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effective sedative
Maintain adequate sedation permitting the completion of the examination
Adverse effects
Incidence of bradycardia, hypotension, respiratory complications and vomiting

Full Information

First Posted
March 8, 2010
Last Updated
October 24, 2013
Sponsor
Federal University of Minas Gerais
Collaborators
Santa Casa de Misericórdia de Belo Horizonte
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1. Study Identification

Unique Protocol Identification Number
NCT01083797
Brief Title
Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate
Official Title
Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Santa Casa de Misericórdia de Belo Horizonte

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Conditions of Brain
Keywords
Sedation, Electroencephalography, Dexmedetomidine, Chloral hydrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine, chloral hydrate
Arm Type
Other
Arm Description
sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine: Precedex, Abbott Laboratories
Intervention Description
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
Intervention Name(s)
Chloral Hydrate
Other Intervention Name(s)
Chloral Hydrate 10% solution (100 mg/ml)
Intervention Description
Initial dose=50 mg/kg
Primary Outcome Measure Information:
Title
electroencephalogram pattern
Description
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.
Time Frame
twenty minutes
Secondary Outcome Measure Information:
Title
Effective sedative
Description
Maintain adequate sedation permitting the completion of the examination
Time Frame
twenty minutes
Title
Adverse effects
Description
Incidence of bradycardia, hypotension, respiratory complications and vomiting
Time Frame
Two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: neurological disorder behavior disorder epilepsy Exclusion Criteria: cardiac disease respiratory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Fernandes
Organizational Affiliation
Santa Casa de Misericórdia de Belo Horizonte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gomez Renato
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
Facility Information:
Facility Name
Santa Casa de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19589455
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.
Results Reference
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PubMed Identifier
18005372
Citation
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.
Results Reference
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Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

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