Deep SedationNCT00639548
ERPS, BIS and Entropy for Neuromonitoring in ICU Patients
An observational study of Deep Sedation and Electroencephalography, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Sedation, Electroencephalography, Event-Related Potentials
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2004to Sep 2007
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients required an elective thoracic surgical intervention under general anesthesia and who were scheduled to the ICU for postoperative care
Who may be able to join
- 18 Years or older
Who cannot join
- ASA class III or higher history of adverse events during former surgery or anesthesia, neurological impairment in the medical history hearing abnormalities.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Departement of Intensive Care Medicine - University Hospital Bern - Inselspital
Bern, 3010
About this study
Official title: Auditory Event-Related Potentials, BIS-Index and Entropy for the Discrimination of Different Levels of Sedation in the ICU Patients
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.
Read the detailed description
Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort and pain. The excessive use of sedatives and analgesics prolongs time on mechanical ventilation, the incidence of nosocomial pneumonia, time spent in the intensive care unit, and increases costs. Strategies to reduce the use of sedatives and analgesics may improve the outcome. Whereas undersedation is mostly easy to identify, oversedation with its associated problems is more difficult to recognize, but should be avoided. While stopping sedation daily helps to avoid gross oversedation, this is not always possible, e.g. due to unstable condition of the patient. Also, accumulation of sedatives and analgesics may occur rapidly, especially in patients with renal and/or liver dysfunction. 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. A relatively new method of processed EEG is Entropy®. Entropy is a non-linear statistic parameter which describes the order of random repetitive signals. In patients it translates the anesthesia-induced "calmer", more synchronized EEG into a single parameter. Spectral entropy can reproducibly indicate the hypnotic effects of propofol, thiopental and different anesthetic gases. The most popular method of processed EEG for assessment of sedation is the bispectral index (BIS-Index®). While BIS has been tested and validated for the use in the operation room with different anesthetics, data on its use in the ICU setting at less deep levels of sedation are controversial. The multiple concomitant medications and heterogeneity of underlying pathologies present a further challenge to the use of neuromonitoring in the ICU.
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.
- Conditions
- Deep Sedation, Electroencephalography, Event-Related Potentials, Evoked Potentials, Auditory
- Keywords
- Deep Sedation, EEG, Event-Related Potentials, Evoked potentials, auditory, BIS-Index, Entropy, ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
Event related Potentials (Amplitudes, latencies) at different clinically relevant sedation levels
Measured: postoperative awakening
Secondary outcomes (2)
BIS-Index at different clinically relevant sedation levels
Measured: postoperative awaakening
Entropy at different clinically relevant sedation levels
Measured: postoperative awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startNov 2004
- Primary completionJul 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639548
- Sponsor's protocol ID
- KIM-NMP4
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 20 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1213/01.ane.0000237394.21087.85.
PubMed 17056949Haenggi M, Ypparila H, Takala J, Korhonen I, Luginbuhl 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):1728-1736. doi: 10.1213/01.ANE.0000135634.46493.0A.
PubMed 15562062
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Event-Related Potentials, BIS-Index and Entropy for the Discrimination of Different Levels of Sedation in the ICU Patients
- ClinicalTrials.gov ID
- NCT00639548
- Acronym / sponsor ID
- KIM-NMP4
- Conditions
- Deep Sedation, Electroencephalography, Event-Related Potentials, Evoked Potentials, Auditory
- Keywords
- Deep Sedation, EEG, Event-Related Potentials, Evoked potentials, auditory, BIS-Index, Entropy, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Nov 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Most critically ill patients receive sedative and analgesic drugs to attenuate discomfort and pain. The excessive use of sedatives and analgesics prolongs time on mechanical ventilation, the incidence of nosocomial pneumonia, time spent in the intensive care unit, and increases costs. Strategies to reduce the use of sedatives and analgesics may improve the outcome. Whereas undersedation is mostly easy to identify, oversedation with its associated problems is more difficult to recognize, but should be avoided. While stopping sedation daily helps to avoid gross oversedation, this is not always possible, e.g. due to unstable condition of the patient. Also, accumulation of sedatives and analgesics may occur rapidly, especially in patients with renal and/or liver dysfunction. 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. A relatively new method of processed EEG is Entropy®. Entropy is a non-linear statistic parameter which describes the order of random repetitive signals. In patients it translates the anesthesia-induced "calmer", more synchronized EEG into a single parameter. Spectral entropy can reproducibly indicate the hypnotic effects of propofol, thiopental and different anesthetic gases. The most popular method of processed EEG for assessment of sedation is the bispectral index (BIS-Index®). While BIS has been tested and validated for the use in the operation room with different anesthetics, data on its use in the ICU setting at less deep levels of sedation are controversial. The multiple concomitant medications and heterogeneity of underlying pathologies present a further challenge to the use of neuromonitoring in the ICU.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients required an elective thoracic surgical intervention under general anesthesia and who were scheduled to the ICU for postoperative care
Key inclusion criteria (1 listed)
- 18 Years or older
Key exclusion criteria (1 listed)
- ASA class III or higher history of adverse events during former surgery or anesthesia, neurological impairment in the medical history hearing abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event related Potentials (Amplitudes, latencies) at different clinically relevant sedation levels
Time frame: postoperative awakening
2 secondary outcomes
BIS-Index at different clinically relevant sedation levels
Time frame: postoperative awaakening
Entropy at different clinically relevant sedation levels
Time frame: postoperative awakening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2008.
- Background: PubMed 17056949Haenggi 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. doi: 10.1213/01.ane.0000237394.21087.85.
- Background: PubMed 15562062Haenggi M, Ypparila H, Takala J, Korhonen I, Luginbuhl 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):1728-1736. doi: 10.1213/01.ANE.0000135634.46493.0A.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Sedation and Electroencephalography, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 1 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 20 Mar 2008. 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 Switzerland. 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.
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?
Event related Potentials (Amplitudes, latencies) at different clinically relevant sedation levels (time frame: postoperative awakening). 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 NCT00639548, 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 20 Mar 2008.