University of Michigan Medical School, University Hospital
Ann Arbor, Michigan, 48109, United States
NCT Number: 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. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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). The investigators 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:
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. If an alert is triggered, the clinician electronically signed into the case receives an alphanumeric page stating "Potentially insufficient anesthesia, please check vaporizers and intravenous lines."
The investigators 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.
Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.
Time frame: Outcome of awareness is assessed 30-days after the operation
By modified intention-to-treat analysis
Time frame: During surgery (45 minutes - 18 hours), measured based on 30 day interviews
Binary variables for whether participants recall dreaming or not.
Time frame: During surgery: (45 minutes - 18 hours)
Time frame: During surgery (45 minutes - 18 hours)
Time frame: During recovery room stay: 30 minutes to 6 hours
measured in time within Post Anesthesia Care Unit ( PACU) until the participant is ready for discharge from PACU based on a composite of factors, including pain and neurologic status
Time frame: During recovery room stay: 30 minutes to 6 hours
Time frame: 30 days after surgery
There is controversy regarding the appropriate technique for assessing awareness during anesthesia with explicit recall. A total cohort was utilized to compare the incidence of awareness with recall as determined by formal interview vs. the incidence of awareness with recall based on spontaneous reports (in the same cohort).
Time frame: Outcome of hemodynamic stability is assessed
Time frame: Outcome of mortality is assessed
Time frame: Outcome of post-traumatic stress disorder is assessed with the covariate of awareness
Time frame: Outcome of hypotension in relationship to induction doses and BIS values will be assessed
Time frame: Outcome of awareness is assessed
Time frame: NEED VALUE HERE
University of Michigan
Other
A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population
Acronym: MACS
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