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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: Completed NA study, sponsored by University of Michigan.
NCT00689091 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 22,185 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1481% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
By modified intention-to-treat analysis
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 |
What the finished NCT00689091 record still lists
NCT00689091 is an interventional study that assigns participants to a tested intervention. Its 22,185 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1481% higher).
The record links to 0 conditions, and to 2 interventions - of which Bispectral Index Monitor is the first listed.
NCT00689091 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00689091's enrollment target sits among peer trials
22,185 10th of 2000 higher than 1,991 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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