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Other Conditions of BrainPhase 3NCT01083797

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

A Phase 3 study testing Dexmedetomidine and Chloral Hydrate in people with Other Conditions of Brain, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 38 years
Conditions the study is for
Other Conditions of Brain
What is being tested?
Dexmedetomidine and Chloral Hydrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteBrazil
Study dates
Dec 2009to Oct 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 38 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • neurological disorder
  • behavior disorder
  • epilepsy

Who cannot join

  • cardiac disease
  • respiratory disease

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Santa Casa de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Dexmedetomidine, Chloral Hydrate
Keywords
Sedation, Electroencephalography, Dexmedetomidine, Chloral hydrate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Dexmedetomidine: Precedex, Abbott Laboratories

    1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1

  • Chloral HydrateDrug

    Also called Chloral Hydrate 10% solution (100 mg/ml)

    Initial dose=50 mg/kg

Study groups in NCT01083797
Study groupRoleWhat they receive
dexmedetomidine, chloral hydrateOthersedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients
Receives: Drug: Dexmedetomidine; Drug: Chloral Hydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: twenty minutes

Secondary outcomes (2)

  1. Effective sedative

    Maintain adequate sedation permitting the completion of the examination

    Measured: twenty minutes

  2. Adverse effects

    Incidence of bradycardia, hypotension, respiratory complications and vomiting

    Measured: Two hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01083797
Sponsor's protocol ID
CEP 106/2009
Status last verified
Oct 2013
First submitted
8 Mar 2010
Last updated
25 Oct 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19589455

  • 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.

    PubMed 18005372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine and Chloral Hydrate in people with Other Conditions of Brain, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

electroencephalogram pattern (time frame: twenty minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01083797, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.

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