Evidence map›Paper›PMID 22990178›Full record

Trial reportAnesthesiology2012

Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial.

George A Mashour, Amy Shanks, Kevin K Tremper, Sachin Kheterpal, Christopher R Turner, Satya Krishna Ramachandran, Paul Picton, Christa Schueller, Michelle Morris, John C Vandervest and 2 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Anesthesiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03285971 (Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure), which is not on this map. Cited by 91 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 8 pooled it
33.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03285971 early_phase1completednot on this mapstarted 2017, after this paper: background citation

Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure

TypeinterventionalSponsorUniversity of MichiganRan2017 to 2021Enrolled53ConditionsCerebral HypoperfusionArmsElectronic CPP pager alert
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 8 syntheses or guidelines pooled it, 272 citations in OpenAlex.

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  6. Anaesthetic interventions for prevention of awareness during surgery.The Cochrane database of systematic reviews · 2016
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31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

George A MashourDepartment of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan 48109-5048, USA. gmashour@umich.edu
Amy Shanks
Kevin K Tremper
Sachin Kheterpal
Christopher R Turner
Satya Krishna Ramachandran
Paul Picton
Christa Schueller
Michelle Morris
John C Vandervest
Nan Lin
Michael S Avidan
Marymount University · USNational Student Clearinghouse Research Center · US

Funding

Michigan Institute for Clinical and Health Research (MICHR) (KL2)KL2RR024987 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$2.8M
NCRR NIH HHS KL2 RR024987NCRR NIH HHS KL2 RR024987-01NIGMS NIH HHS L30 GM085816
6 · The paper itself

Abstract

backgroundIntraoperative awareness with explicit recall occurs in approximately 0.15% of all surgical cases. Efficacy trials based on the Bispectral Index® (BIS) monitor (Covidien, Boulder, CO) and anesthetic concentrations have focused on high-risk patients, but there are no effectiveness data applicable to an unselected surgical population.

methodsWe conducted a randomized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center. Surgical cases were randomized to alerting algorithms based on either BIS values or anesthetic concentrations. The primary outcome was the incidence of definite intraoperative awareness; prespecified secondary outcomes included postanesthetic recovery variables.

resultsThe study was terminated because of futility. At interim analysis the incidence of definite awareness was 0.12% (11/9,376) (95% CI: 0.07-0.21%) in the anesthetic concentration group and 0.08% (8/9,460) (95% CI: 0.04-0.16%) in the BIS group (P = 0.48). There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting. By post hoc secondary analysis, the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention (P = 0.001; 95% CI: 1.7-13.1).

conclusionThis negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocols based on either BIS values or anesthetic concentration. By post hoc analysis, a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care.

Indexed as

AdultAlgorithmsAnesthesia, GeneralAnesthesia Recovery PeriodAnestheticsConsciousness MonitorsFemaleHumansIntraoperative AwarenessMaleMental RecallMiddle AgedTreatment FailureTreatment OutcomeAnesthetics

Identifiers

PMID22990178
PMCPMC3447261
OpenAlexW2162019025

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.