Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

October 24, 2013 updated by: Renato Santiago Gomez, Federal University of Minas Gerais

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Belo Horizonte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 38 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • neurological disorder
  • behavior disorder
  • epilepsy

Exclusion Criteria:

  • cardiac disease
  • respiratory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: dexmedetomidine, chloral hydrate
sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
Drug: Dexmedetomidine
1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1
Other Names:
  • Dexmedetomidine: Precedex, Abbott Laboratories
Drug: Chloral Hydrate
Initial dose=50 mg/kg
Other Names:
  • Chloral Hydrate 10% solution (100 mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
twenty minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Santa Casa de Misericórdia de Belo Horizonte

Investigators

  • Principal Investigator: Magda Fernandes, Santa Casa de Misericordia de Belo Horizonte
  • Study Director: Gomez Renato, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (ESTIMATE)

March 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 106/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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