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NCT00689091 · ClinicalTrials.gov registry record · NA
Bispectral Index (BIS) Versus Electronic Alerts in the Prevention of Anesthesia Awareness: the Michigan Awareness Control Study
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 22,185
- Enrollment target
NCT00689091 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 22,185 participants.
The verdict
NCT00689091, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 22,185 participants
- Enrollment target
Study Summary
Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.
Interventions
- DEVICE Bispectral Index Monitor
- DEVICE Electronic MAC alert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22,185 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00689091
The ClinicalTrials.gov registry entry for NCT00689091 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22,185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bispectral Index Monitor is the first listed.
NCT00689091 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00689091 about?
NCT00689091 is a clinical study titled "Bispectral Index (BIS) Versus Electronic Alerts in the Prevention of Anesthesia Awareness: the Michigan Awareness Control Study". Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monit...
What is the current status of trial NCT00689091?
This trial is currently completed. It is a NA study. The enrollment target is 22,185 participants. The study started on 2008-05. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00689091?
The interventions under investigation include: Bispectral Index Monitor (DEVICE), Electronic MAC alert (DEVICE).
Who is sponsoring clinical trial NCT00689091?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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