Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Michigan Foundation for Anesthesia Education and Research American Society of Anesthesiologists Washington University School of Medicine University of Chicago University of Manitoba |
---|---|
Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00689091 |
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. We propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.
Condition | Intervention | Phase |
---|---|---|
Awareness During General Anesthesia |
Device: Bispectral Index Monitor Device: Electronic MAC alert |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Parallel Assignment |
Official Title: | A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
BIS group: Experimental
This group will have BIS values visible and will receive alerts when the value is >60.
|
Device: Bispectral Index Monitor |
MAC Alert: Active Comparator
This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.
|
Device: Electronic MAC alert |
Electronic alerts have been developed and employed at our institution and have been shown to increase compliance with both clinical and administrative tasks (O'Reilly et al, 2006; Kheterpal et al, 2007). We have developed electronic alerts for the purpose of informing the clinician of potentially insufficient anesthesia based on minimum alveolar concentration (MAC). The algorithm is as follows:
Conditions for an "active case" are:
The alerting system checks the MOST RECENT value in the last 5 minutes of
This will be the protocol in the MAC-guided group. In the BIS-guided group an electronic alert will be sent if the BIS value is >60.
We are collaborating with Washington University, the University of Chicago, and the University of Mannitoba, who will also be testing a MAC-based protocol in comparison to the BIS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy Shanks, M.S. | 734-936-0063 | ashanks@umich.edu |
United States, Michigan | |
University of Michigan Medical School, University Hospital | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: George A. Mashour, M.D., Ph.D. 734-936-4280 gmashour@umich.edu | |
Principal Investigator: George A. Mashour, M.D., Ph.D. |
Principal Investigator: | George A. Mashour, M.D., Ph.D. | University of Michigan |
Responsible Party: | University of Michigan Medical School ( George A. Mashour, M.D., Ph.D., Assistant Professor of Anesthesiology and Neurosurgery ) |
Study ID Numbers: | HUM00013626 |
Study First Received: | May 29, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00689091 |
Health Authority: | United States: Institutional Review Board |
Awareness BIS Monitor electronic alerts |
minimum alveolar concentration |