Bispectral Index (BIS) Versus Electronic Alerts in the Prevention of Anesthesia Awareness: the Michigan Awareness Control Study

NCT ID: NCT00689091

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-06-30

Brief 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.

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). 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:

• 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. case has been identified as a general anesthetic

4. "anesthesia induction end" has already been documented

5. request for recovery room bed or transport to an intensive care unit has not been documented

6. surgical dressing completion has not been documented

• The alerting system checks the most recent value (within a specified time period) of:

1. Et Sevoflurane (MAC=2.0)

2. Et Isoflurane (MAC=1.2)

3. Et Desflurane (MAC=6)

4. Et Nitrous Oxide (MAC=105) and compares it to the MAC of each agent. It adds the resulting MAC values together for "current total MAC."

• The system then checks for a charted 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 concentrations at which 50% of patients do not move in response to a noxious stimulus. Since the investigators do not have the technology at our institution to calculate Cp50 or Cp50-awake, the investigators have chosen the above propofol dose as an initial value based on clinical experience. The resultant MAC equivalent is added to current total MAC.
• The system next checks for a dexmedetomidine infusion with a rate of 0.2 mcg/kg/hour or greater. If present, it multiplies the current total inhalational MAC by 2, as dexmedetomidine can reduce MAC by 50%.
• At this point, the "current total MAC" is defined as: Et Sevo /2 + Et Iso /1.2 + Et Des/6 + Et Nitrous /105 + propofol rate (in mcg/kg/min)/150. If dexmedetomidine is >0.2 mcg/kg/hour, inhalational MAC is multiplied by 2.
• 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. 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.

Conditions

Awareness During General Anesthesia

Keywords

Awareness; BIS Monitor; electronic alerts; minimum; alveolar; concentration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

BIS group

This group will have BIS values visible and will receive alerts when the value is \>60.

Group Type: EXPERIMENTAL

Bispectral Index Monitor

Intervention Type: DEVICE

Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.

MAC Alert

This group will receive an alert if total MAC (including intravenous infusions) is \<0.5 age-adjusted.

Group Type: ACTIVE_COMPARATOR

Electronic MAC alert

Intervention Type: DEVICE

Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.

Interventions

Bispectral Index Monitor

Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.

Intervention Type: DEVICE

Electronic MAC alert

Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Anesthesia Education and Research

OTHER

Sponsor Role: collaborator

American Society of Anesthesiologists

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

George Mashour

Assistant Professor of Anesthesiology and Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George A. Mashour, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Medical School, University Hospital

Ann Arbor, Michigan, United States

Countries

United States

References

Vance JL, Shanks AM, Woodrum DT. Intraoperative bispectral index monitoring and time to extubation after cardiac surgery: secondary analysis of a randomized controlled trial. BMC Anesthesiol. 2014 Sep 18;14:79. doi: 10.1186/1471-2253-14-79. eCollection 2014.

Reference Type: DERIVED

PMID: 25249789 (View on PubMed)

Shanks AM, Avidan MS, Kheterpal S, Tremper KK, Vandervest JC, Cavanaugh JM, Mashour GA. Alerting thresholds for the prevention of intraoperative awareness with explicit recall: a secondary analysis of the Michigan Awareness Control Study. Eur J Anaesthesiol. 2015 May;32(5):346-53. doi: 10.1097/EJA.0000000000000123.

Reference Type: DERIVED

PMID: 25010744 (View on PubMed)

Avidan MS, Palanca BJ, Glick D, Jacobsohn E, Villafranca A, O'Connor M, Mashour GA; BAG-RECALL Study Group. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients. BMC Anesthesiol. 2009 Nov 30;9:8. doi: 10.1186/1471-2253-9-8.

Reference Type: DERIVED

PMID: 19948045 (View on PubMed)

Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7.

Reference Type: DERIVED

PMID: 19891771 (View on PubMed)

Other Identifiers

HUM00013626

Identifier Type: -

Identifier Source: org_study_id