N/A
N=21,601
Bispectral Index (BIS) Versus Electronic Alerts in the Prevention of Anesthesia Awareness: the Michigan Awareness Control Study
Awareness During General Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT00689091 ↗Enrolled (actual)
21,601
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. — 0.08; 0.12 Percentage of participants/30days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bispectral Index Monitor (Device); Electronic MAC alert (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. |
0.08; 0.12 | — |
| SECONDARY Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring |
9174; 9352; 202; 108 | — |
| SECONDARY Percentage of Cases With Electronic Alerts |
2.4; 2.3 | — |
| SECONDARY Overall Use of Anesthetics Comparing the BIS to MAC Alerts. |
0.9; 0.9 | — |
| SECONDARY Time Till Discharge Readiness |
98; 95 | — |
| SECONDARY Number of Participants Without Nausea or Vomiting |
6184; 4042; 7149; 4617 | — |
| SECONDARY Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence. |
3; 19; 18833; 18817 | — |
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age, English-speaking, available for follow-up interview at one month.
Exclusion Criteria
- Pre-existing neurologic or neuropsychiatric condition, surgical manipulation around forehead, not available for follow-up interview.
Data sourced from ClinicalTrials.gov (NCT00689091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.