NCT00682825

Brief Summary

The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for phase_4

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2011

Enrollment Period

2.8 years

First QC Date

May 16, 2008

Last Update Submit

January 3, 2011

Conditions

Explicit Recall of Intra-Operative Events

Keywords

AnesthesiaAwarenessBispectralBISRecall

Outcome Measures

Primary Outcomes (1)

  • The incidence of explicit recall of events during the surgical and anesthetic periods.

    Three years

Secondary Outcomes (25)

  • Meta-analysis for anesthesia awareness incorporating higher risk patients from the completed B-Unaware Trial (NCT00281489), the BAG-RECALL Trial, and the Michigan Awareness Control Study (MACS)(NCT00689091).

    Three years

  • Incidence of post-traumatic stress disorder (PTSD).

    Five years

  • Association between type of awareness event and PTSD, and whether the PTSD is associated with late reporting (30 days) of awareness.

    5 years

  • Types of dreams and their relationship to BIS and ETAG.

    Three years

  • The relationship between deep hypnotic time, anesthetic dose (MAC), mean arterial pressure, and end tidal carbon dioxide, and early (one-month) and late (one-year) mortality.

    Four years

  • +20 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Bispectral index-guided protocol

Behavioral: Bispectral index protocol

2

ACTIVE COMPARATOR

End-tidal anesthetic gas-guided protocol

Behavioral: End tidal anesthetic gas-guided

Interventions

Bispectral index protocolBEHAVIORAL

Aim to titrate anesthesia to maintain BIS between 40 and 60.

1
End tidal anesthetic gas-guidedBEHAVIORAL

Aim to maintain anesthetic gas between 0.7 and 1.3 MAC equivalents

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MUST HAVE:
  • General Anesthesia with volatile anesthetic
  • PATIENT CHARACTERISTICS
  • Major Criteria (Must have any 1 of the following:)
  • Planned open heart surgery
  • Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
  • EF\<40%
  • Prior history of awareness (recall)
  • History of difficult intubation or anticipated difficult intubation
  • ASA IV or V status
  • Aortic stenosis
  • End stage lung disease
  • Marginal exercise tolerance not secondary to musculoskeletal dysfunction
  • Pulmonary hypertension
  • Daily alcohol consumption

You may not qualify if:

  • Surgical procedure that prevents the use of the BIS (e.g. surgery of forehead)
  • Patient positioning prevents use of the BIS
  • Surgery with wake-up test.
  • Less than 18 years of age
  • Vulnerable populations, such as those with dementia and those unable to provide informed consent.
  • Stroke with residual neurological deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Chicago

Chicago, Illinois, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Related Publications (8)

  • Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.

    PMID: 15172773BACKGROUND

  • Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.

    PMID: 18337600BACKGROUND

  • 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.

    PMID: 19948045BACKGROUND

  • 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.

    PMID: 19891771BACKGROUND

  • Mashour GA, Esaki RK, Tremper KK, Glick DB, O'Connor M, Avidan MS. A novel classification instrument for intraoperative awareness events. Anesth Analg. 2010 Mar 1;110(3):813-5. doi: 10.1213/ANE.0b013e3181b6267d. Epub 2009 Aug 27.

    PMID: 19713251BACKGROUND

  • Willingham M, Ben Abdallah A, Gradwohl S, Helsten D, Lin N, Villafranca A, Jacobsohn E, Avidan M, Kaiser H. Association between intraoperative electroencephalographic suppression and postoperative mortality. Br J Anaesth. 2014 Dec;113(6):1001-8. doi: 10.1093/bja/aeu105. Epub 2014 May 22.

    PMID: 24852500DERIVED

  • Whitlock EL, Torres BA, Lin N, Helsten DL, Nadelson MR, Mashour GA, Avidan MS. Postoperative delirium in a substudy of cardiothoracic surgical patients in the BAG-RECALL clinical trial. Anesth Analg. 2014 Apr;118(4):809-17. doi: 10.1213/ANE.0000000000000028.

    PMID: 24413548DERIVED

  • Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.

    PMID: 21848460DERIVED

Related Links

Study Officials

  • Michael S Avidan, MBBCh FCA

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • David Glick, MD

    University of Chicago

    STUDY DIRECTOR

  • Eric Jacobsohn, MBChB

    University of Manitoba

    STUDY CHAIR

  • Michael O'Connor, MD

    University of Chicago

    STUDY DIRECTOR

  • Alex S Evers, MD

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 22, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2010

Last Updated

January 4, 2011

Record last verified: 2011-01

Locations

US(2)CA(1)