ERPS, BIS and Entropy for Neuromonitoring in ICU Patients

NCT00639548 | Completed

• 1 other identifier: KIM-NMP4
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Deep Sedation; Electroencephalography; Event-Related Potentials; Evoked Potentials, Auditory

Keywords

Deep Sedation; EEG; Event-Related Potentials; Evoked potentials, auditory; BIS-Index; Entropy; ICU

Outcome Measures

Primary Outcomes (1)

• Event related Potentials (Amplitudes, latencies) at different clinically relevant sedation levels

  postoperative awakening

Secondary Outcomes (2)

• BIS-Index at different clinically relevant sedation levels

  postoperative awaakening

• Entropy at different clinically relevant sedation levels

  postoperative awakening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients required an elective thoracic surgical intervention under general anesthesia and who were scheduled to the ICU for postoperative care

You may qualify if:

• Years or older

You may not qualify if:

• ASA class III or higher history of adverse events during former surgery or anesthesia, neurological impairment in the medical history hearing abnormalities.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• GE Healthcare: collaborator

Study Sites (1)

Departement of Intensive Care Medicine - University Hospital Bern - Inselspital

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 17056949 BACKGROUND

• Haenggi 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.

  PMID: 15562062 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 20, 2008
• Study Start: November 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2007
• Last Updated: March 20, 2008

Record last verified: 2008-03

Locations

CH (1)