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Sponsors and Collaborators: |
University Hospital Inselspital, Berne GE Healthcare |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00641563 |
Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedation scores. Attempts to improve sedation monitoring through the use of the electroencephalogram(EEG) have been disappointing. Derived variables based on the unstimulated EEG fail to predict the response to external stimuli at the clinically most relevant light-to-moderate sedation levels, and the overlap between moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers during propofol sedation, independent of the concomitant administration of remifentanil. This approach has a potential clinical application for improved monitoring of sedation. Since the effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor sedation needs to be evaluated with different sedative drugs. Therefore we will administer two widely used drug combinations (dexmedetomidine/remifentanil and midazolam/remifentanil) in healthy volunteers and record ERPS and processed EEG during clinical relevant sedation levels
Condition | Intervention |
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Conscious Sedation Deep Sedation Critical Care |
Device: Measurement of auditory ERPS (event related potentials) during sedation |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Active Control, Factorial Assignment |
Official Title: | The Effects of Dexmedetomidine/Remifentanil and Midazolam/Remifentanil on Auditory-Evoked Potentials and Electroencephalogram at Light-to-Moderate Sedation Levels in Healthy Subjects |
Enrollment: | 10 |
Study Start Date: | March 2004 |
Study Completion Date: | June 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dex/Remi: Active Comparator
Sedation with dexmedetomidine and remifentanil
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Device: Measurement of auditory ERPS (event related potentials) during sedation
Measurement of the amplitudes of auditory event related potentials (time locked, averaged acoustic evoked potential 100 msec after auditory stimulus) and EEG with an custom built, prototype electroencephalogram device from GE Healthcare and processed EEG (BIS-Index and Response- and State Entropy)
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Mida/Remi: Active Comparator
sedation with midazolam and remifentanil
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Device: Measurement of auditory ERPS (event related potentials) during sedation
Measurement of the amplitudes of auditory event related potentials (time locked, averaged acoustic evoked potential 100 msec after auditory stimulus) and EEG with an custom built, prototype electroencephalogram device from GE Healthcare and processed EEG (BIS-Index and Response- and State Entropy)
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Sedation may be necessary in intensive care to facilitate diverse therapeutic interventions, but the use of sedative drugs may increase the risk of delirium and long-term cognitive impairment. Thus the implementation and monitoring of sedation remains difficult despite the use of sedation protocols and clinical sedation scores. Attempts to improve sedation monitoring through the use of the electroencephalogram (EEG) have been disappointing. Derived variables based on the unstimulated EEG fail to predict the response to external stimuli at the clinically most relevant light-to-moderate sedation levels, and the overlap between moderate and deep sedation levels is wide. We have demonstrated that long-latency auditory evoked potentials (ERPs)can be used to avoid deep levels of sedation in healthy volunteers during propofol sedation, independent of the concomitant administration of remifentanil. This approach has a potential clinical application for improved monitoring of sedation. Since the effects of different sedative drugs on the EEG may vary widely, the use of ERPs to monitor sedation needs to be evaluated with different sedative drugs. The alpha-2 agonist dexmedetomidine (dex) has been approved for short-term sedation in surgical intensive care unit (ICU) patients. Preliminary data suggest that the risk of delirium may be substantially reduced when dexmedetomidine is used to produce sedation.
Since dexmedetomidine acts via different receptors and brain areas than do benzodiazepines and propofol, its impact on the brain electrophysiology may also be different. The assessment of dexmedetomidine's effects on the EEG and ERPs at various sedation levels has been limited in humans. We hypothesized that dexmedetomidine and midazolam (mida), each given in combination with remifentanil (remi), would induce the same changes in EEG and long-latency ERPs during light-to-moderate levels of sedation in healthy subjects, despite the different quality of sedation that they provide. The opioid remifentanil was added because virtually all patients in the ICU have some level of pain and receive an opioid analgesic in combination with a sedative.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Department of Intensive Care Medicine, university Hospital Bern - Inselspital ( Matthias Haenggi ) |
Study ID Numbers: | KIM-NMP3 |
Study First Received: | February 25, 2008 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00641563 History of Changes |
Health Authority: | Switzerland: Ethikkommission |
dexmedetomidine midazolam remifentanil Electroencephalography Event related potentials |
BIS Bispectral Index Response Entropy State Entropy |
Anesthetics, Intravenous Neurotransmitter Agents Adrenergic alpha-Agonists Remifentanil Adrenergic Agents Anesthetics Central Nervous System Depressants Healthy Midazolam |
Adrenergic Agonists Anesthetics, General Analgesics, Non-Narcotic Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
Anesthetics, Intravenous Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Remifentanil Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Adrenergic Agonists Pharmacologic Actions |
Anesthetics, General Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |