Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG)

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00641563
First received: February 25, 2008
Last updated: October 13, 2011
Last verified: October 2011
Results First Received: April 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Conscious Sedation
Deep Sedation
Critical Care
Interventions: Drug: Dexmedetomidine
Drug: Midazolam
Drug: Remifentanil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dex/Remi Followed by Mida/Remi Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week
Mida/Remi Followed by Dex/Remi Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week

Participant Flow for 2 periods

Period 1:   Infusion 1
    Dex/Remi Followed by Mida/Remi     Mida/Remi Followed by Dex/Remi  
STARTED     5     5  
COMPLETED     5     5  
NOT COMPLETED     0     0  

Period 2:   Infusion 2
    Dex/Remi Followed by Mida/Remi     Mida/Remi Followed by Dex/Remi  
STARTED     5     5  
COMPLETED     5     5  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Study Participants Both arms combined

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  24  ± 3  
Gender  
[units: participants]
 
Female     0  
Male     10  
Region of Enrollment  
[units: participants]
 
Switzerland     10  



  Outcome Measures
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1.  Primary:   Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels   [ Time Frame: awake + 3 sedation levels (RS2/3/4) (20 minutes each) ]

2.  Secondary:   BIS-Index Awake and 3 Sedation Levels (RS 2/3/4)   [ Time Frame: awake and 3 sedation levels (RS 2/3/4) 20 min each ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. M. Hänggi
Organization: University Hospital Bern, Switzerland
phone: 0316323029
e-mail: matthias.haenggi@insel.ch


Publications of Results:
Other Publications:

Responsible Party: Matthias Haenggi, Department of Intensive Care Medicine, university Hospital Bern - Inselspital
ClinicalTrials.gov Identifier: NCT00641563     History of Changes
Other Study ID Numbers: KIM-NMP3
Study First Received: February 25, 2008
Results First Received: April 27, 2009
Last Updated: October 13, 2011
Health Authority: Switzerland: Ethikkommission