跳至主要内容
临床试验/NCT00689091
NCT00689091已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 22,185 人开始时间: 2008年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22,185
试验地点
2
主要终点
The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups.

研究概览

简要总结

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.

详细描述

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."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age, English-speaking, available for follow-up interview at one month.

排除标准

  • Pre-existing neurologic or neuropsychiatric condition, surgical manipulation around forehead, not available for follow-up interview.

研究组 & 干预措施

BIS group

Experimental

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

干预措施: Bispectral Index Monitor (Device)

MAC Alert

Active Comparator

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

干预措施: Electronic MAC alert (Device)

结局指标

主要结局

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

时间窗: Outcome of awareness is assessed 30-days after the operation

By modified intention-to-treat analysis

次要结局

  • Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring(During surgery (45 minutes - 18 hours), measured based on 30 day interviews)
  • Percentage of Cases With Electronic Alerts(During surgery: (45 minutes - 18 hours))
  • Overall Use of Anesthetics Comparing the BIS to MAC Alerts.(During surgery (45 minutes - 18 hours))
  • Time Till Discharge Readiness(During recovery room stay: 30 minutes to 6 hours)
  • Number of Participants Without Nausea or Vomiting(During recovery room stay: 30 minutes to 6 hours)
  • Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence.(30 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Mashour

Assistant Professor of Anesthesiology and Neurosurgery

University of Michigan

研究点 (2)

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