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Bispectral Index (BIS) Versus Electronic Alerts in the Prevention of Awareness (MACS)
This study is currently recruiting participants.
Verified by University of Michigan, May 2008
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
  Purpose

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

MedlinePlus related topics: Anesthesia Nausea and Vomiting
U.S. FDA Resources
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

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The incidence of awareness with explicit recall in the BIS versus MAC alert groups. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Meta-Analysis of awareness events in conjunction with the BAG-RECALL study based at Washington University. [ Designated as safety issue: Yes ]
  • Incidence of Post-traumatic stress disorder. [ Designated as safety issue: Yes ]
  • Predictors of post-traumatic stress disorder based on the type of awareness event. [ Designated as safety issue: Yes ]
  • Incidence and type of dreams during anesthesia in conjunction with MAC or BIS values. [ Designated as safety issue: No ]
  • The relationship between cumulative deep hypnotic time, anesthetic doses, and mortality. [ Designated as safety issue: Yes ]
  • Relationship between BIS values and hemodynamic parameters. [ Designated as safety issue: Yes ]
  • Analysis of interrupted monitoring during the use of the BIS. [ Designated as safety issue: Yes ]
  • Effect of electronic alerts on the clinical behavior of the anesthesia provider. [ Designated as safety issue: No ]
  • BIS values and anesthetic dosing of chronic pain patients. [ Designated as safety issue: No ]
  • Overall use of anesthetics comparing the BIS to MAC alerts. [ Designated as safety issue: No ]
  • PACU pain scores, neurologic exam, and discharge time in relationship to BIS values. [ Designated as safety issue: Yes ]
  • Incidence of post-operative nausea and vomiting in relationship to BIS values. [ Designated as safety issue: Yes ]
  • Anesthetic induction doses, hypotension, and BIS values. [ Designated as safety issue: Yes ]

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

Detailed Description:

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:

  • Every 5 minutes the alerting system checks every active case in our operating rooms. It takes approximately 1 second for this scan of all active cases to occur.
  • Conditions for an "active case" are:

    1. data capture is possible (i.e., not a paper record)
    2. data capture is active (i.e., "patient in room" has been electronically entered and end-tidal [Et] CO2 is detected)
    3. "anesthesia induction end" has already been documented
    4. request for recovery room bed or transport to an intensive care unit has NOT been documented
  • The alerting system checks the MOST RECENT value in the last 5 minutes of

    1. Et Sevoflurane (MAC-2.0)
    2. Et Isoflurane (MAC-1.2)
    3. Et Nitrous Oxide (MAC-105) and compares to the MAC of each agent. It adds the resulting MACs together.
  • It then checks for a propofol infusion in mcg/kg/min and divides by 150, assuming that 150 mcg/kg/min is 1.0 MAC for propofol. The analogous concept of MAC for propofol is "Cp50"- the plasma or blood concentration at which 50% of patients do not move in response to a noxious stimulus. Since we do not have the technology at our institution to routinely analyze intraoperative propofol levels (and thus cannot establish a Cp50-awake), we have chosen the above dose based on clinical experience.
  • It then checks for a dexmedetomidine infusion with a rate of 0.2 mcg/kg/min or greater. If present, it adds 0.50 to the current total MAC, as dexmedetomidine can reduce MAC by 50% (Aantaa et al, 1997).
  • The "current" MAC is then defined as: Et Sevo /2 + Et Iso / 1.2 + Et Nitrous /105 + propofol rate/100 + 0.50 if dexmedetomidine is >/- 0.2 mcg/kg/min.
  • If this total mac < 0.50, it checks to see if a bolus of propofol, midazolam, etomidate, or thiopental has been given in the preceding 10 minutes.
  • It alerts the clinician signed into the case within 30-60 seconds if total age-adjusted MAC < 0.50 AND no bolus has been documented in the last 10 minutes.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689091

Contacts
Contact: Amy Shanks, M.S. 734-936-0063 ashanks@umich.edu

Locations
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.            
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
Investigators
Principal Investigator: George A. Mashour, M.D., Ph.D. University of Michigan
  More Information

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

Keywords provided by University of Michigan:
Awareness
BIS Monitor
electronic alerts
minimum
alveolar
concentration

ClinicalTrials.gov processed this record on January 16, 2009