Electroencephalography Clinical Trial
Official title:
Auditory Event-Related Potentials, BIS-Index and Entropy for the Discrimination of Different Levels of Sedation in the ICU Patients
Verified date | March 2008 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort
and pain. The excessive use of sedatives and analgesics has undesirable effects for
patients. Whereas undersedation is mostly easy to identify, oversedation with its associated
problems is more difficult to recognize. Stopping sedation daily helps to avoid gross
oversedation, but this is not always possible. Monitoring the depth of sedation is difficult
and is currently based on clinical assessment and the use of clinical scoring systems. These
scoring systems cannot be applied continuously, they are subjective and the level of
consciousness can be altered when sedation is assessed.
Several methods based on the electroencephalogram have been tested to avoid these problems,
but the results have been disappointing so far, so the BIS Monitor an dthe Entropy
monitor.We have previously shown that the time-locked cortical response to standard external
stimuli (long-latency auditory evoked potentials or event-related potentials; ERPs) can
discriminate between clinically relevant light to moderate and deep sedation levels in
healthy volunteers, when sedation is induced with a combination of propofol or midazolam
with remifentanil.
We therefore hypothesized that ERPs may be used to monitor the depth of sedation in ICU
patients as well. As the first step to test this hypothesis, we evaluated the use of ERPs to
assess the level of sedation in patients undergoing elective major surgery and admitted to
the ICU for short term postoperative mechanical ventilation.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2007 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 Years or older Exclusion Criteria: - ASA class III or higher history of adverse events during former surgery or anesthesia, neurological impairment in the medical history hearing abnormalities. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Departement of Intensive Care Medicine - University Hospital Bern - Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | GE Healthcare |
Switzerland,
Haenggi M, Ypparila H, Hauser K, Caviezel C, Korhonen I, Takala J, Jakob SM. The effects of dexmedetomidine/remifentanil and midazolam/remifentanil on auditory-evoked potentials and electroencephalogram at light-to-moderate sedation levels in healthy subjects. Anesth Analg. 2006 Nov;103(5):1163-9. — View Citation
Haenggi M, Ypparila H, Takala J, Korhonen I, Luginbühl M, Petersen-Felix S, Jakob SM. Measuring depth of sedation with auditory evoked potentials during controlled infusion of propofol and remifentanil in healthy volunteers. Anesth Analg. 2004 Dec;99(6):1728-36, table of contents. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event related Potentials (Amplitudes, latencies) at different clinically relevant sedation levels | postoperative awakening | No | |
Secondary | BIS-Index at different clinically relevant sedation levels | postoperative awaakening | No | |
Secondary | Entropy at different clinically relevant sedation levels | postoperative awakening | No |
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