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Completed

NCT Number: NCT00689091

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

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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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Medical School, University Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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:
  • data capture is possible (i.e., not a paper record)
  • data capture is active (i.e., "patient in room" has been electronically entered and end-tidal [Et] CO2 is detected)
  • case has been identified as a general anesthetic
  • "anesthesia induction end" has already been documented
  • request for recovery room bed or transport to an intensive care unit has not been documented
  • surgical dressing completion has not been documented
  • The alerting system checks the most recent value (within a specified time period) of:
  • Et Sevoflurane (MAC=2.0)
  • Et Isoflurane (MAC=1.2)
  • Et Desflurane (MAC=6)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bispectral Index Monitor

Device

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

Electronic MAC alert

Device

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

Primary outcomes

  1. The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups.

    Time frame: Outcome of awareness is assessed 30-days after the operation

    By modified intention-to-treat analysis

Secondary outcomes

  1. Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring

    Time frame: During surgery (45 minutes - 18 hours), measured based on 30 day interviews

    Binary variables for whether participants recall dreaming or not.

  2. Percentage of Cases With Electronic Alerts

    Time frame: During surgery: (45 minutes - 18 hours)

  3. Overall Use of Anesthetics Comparing the BIS to MAC Alerts.

    Time frame: During surgery (45 minutes - 18 hours)

  4. Time Till Discharge Readiness

    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

  5. Number of Participants Without Nausea or Vomiting

    Time frame: During recovery room stay: 30 minutes to 6 hours

  6. Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence.

    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).

Other outcomes

  1. Relationship Between BIS Values and Hemodynamic Parameters.

    Time frame: Outcome of hemodynamic stability is assessed

  2. The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality.

    Time frame: Outcome of mortality is assessed

  3. Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event.

    Time frame: Outcome of post-traumatic stress disorder is assessed with the covariate of awareness

  4. Anesthetic Induction Doses, Hypotension, and BIS Values.

    Time frame: Outcome of hypotension in relationship to induction doses and BIS values will be assessed

  5. Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University.

    Time frame: Outcome of awareness is assessed

  6. Incidence of Post-traumatic Stress Disorder.

    Time frame: NEED VALUE HERE

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Society of Anesthesiologists
  • Foundation for Anesthesia Education and Research
  • University of Chicago
  • University of Manitoba
  • Washington University School of Medicine

Registry information

Official study title

A Prospective, Randomized, Controlled Trial Comparing Bispectral Index Monitoring to Electronic Alerts for Prevention of Awareness During Anesthesia in the General Population

Acronym: MACS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2008
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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