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Awareness in Anaesthesia – B-Aware and B-

Unaware trials.

Bispectral Index Monitoring to Prevent Awareness During Anaesthesia: the B-

Aware Randomised Controlled Trial.

Myles PS, Leslie K, McNeil J et al.

Lancet. 2004 May 29; 363 (9423): 1757-63.

Aim of Study

“… assess whether BIS monitoring decreases the incidence of awareness during relaxant general anaesthesia in routine surgical
patients at high risk of awareness.” (pg. 1757)

Design and Location

Prospective multicenter, double-blind, randomised controlled trial

Mainly Australia and New Zealand, some input from UK and Thailand

Methodology

Inclusion Criteria:

Surgical patients undergoing relaxant general anaesthesia

≥ 18 y.o.
≥ 1 risk factor for awareness

Exclusion Criteria:

Inadequate comprehension of the English language, traumatic brain injury, memory impairment, psychosis,
known or suspected EEG abnormality (e.g. epilepsy, previous brain resection, or scarring), or were not expected
 to be available for interview postoperatively

Total of 2463 patients included; randomised to ‘BIS’ vs. ‘routine care’

BIS group n = 1225; target BIS 40 – 60

Routine Care group n = 1238; BIS monitor turned off
Anaesthetic technique at discretion of anaesthestist

Primary Outcome

Incidence of confirmed awareness

Assessed by ‘structured questionnaire’ following recovery from GA (2 – 6 hours), 24 – 36 hours and 30 days
post-op
Committee of 3 experienced anaesthetists to identify “Awareness”, “Possible awareness” or “No awareness”

Secondary Outcomes

Possible awareness
Recovery times
Hypnotic drug administration
Incidence of marked hypotension
Anxiety and depression
Patient’s satisfaction
Major complications
30-day mortality

Statistics

Primary Outcome – Fisher’s exact test; expressed as proportions, odds ratios with 95% confidence intervals (CIs)
and p values
Secondary Outcomes – Variety of other statistical analyses (mainly Fisher’s exact test or Χ2 test)

Results

2 reports of “Awareness” in BIS group vs. 11 reports of “Awareness” in routine care group (p = 0.022)
Reduced risk of awareness by 82% (95% CI 17 to 98%) if BIS used
In both reports of “Awareness” in BIS group, BIS readings were >60 for 5 mins and 9 mins!
Dose of Midazolam (2 mg vs. 2.5 mg, p = 0.017) and Target Plasma Conc. (if TIVA used; 2 mg/L vs. 2.4 mg/L, p =
0.016) were significantly less in BIS vs. routine care group
Time to eye opening (mins, 9 vs. 10, p = 0.003) was quicker (i.e. faster recovery) in BIS vs. routine care group

Conclusions/Discussions

Use of BIS reduces risk of awareness in adult population at higher risk of awareness undergoing relaxant GA
Number needed to treat = 138
Cost of preventing one case of awareness = $2,200

Stated Limitations from the Study

 Only focused on at-risk patients à ?Generalisability for entire adult population
Lack of control in ‘routine care’ group à ?Prevention of awareness due to increased vigilance when using BIS
No direct comparison of BIS to other standard forms of anaesthetic monitoring (e.g. MAC or ETVolatile)

***************************************************

Anesthesia Awareness and the Bispectral index. (B-Unaware Trial)

Avidan MS, Zhang L, Burnside BA et al.

New England Journal of Medicine. 2008 Mar 13; 358 (11): 1097-108.

Aim of Study

“… determine whether, in patients at high risk, the incidence of anesthesia awareness is reduced when clinicians follow a BIS-
guided protocol rather than an ETAG-guided protocol.” (pg. 1098)

Design and Location

Prospective single-center, randomised controlled trial

Barnes-Jewish Hospital (Missouri, US)

Methodology

Inclusion Criteria:

Surgical patients undergoing general anaesthesia with volatiles

≥ 18 y.o.
High risk for awareness (≥ 1 major criteria or ≥ 2 minor criteria)

Exclusion Criteria:

Surgical procedure/positioning prevented BIS monitoring

Wake-up test required intra-operatively
Dementia or history of stroke with residual neurological deficits
Unable to provide informed consent

Total of 1941 patients included; randomised to ‘BIS-guided’ vs. ‘end-tidal anaesthetic gas (ETAG)’

BIS-guided group n = 967; target BIS 40 – 60 with no MAC range

ETAG group n = 974; target MAC 0.7 – 1.3, no BIS number visible

Primary Outcome

Incidence of confirmed awareness

Assessed by Brice questionnaire within 24 hours, 24 – 72 hours and 30 days post-extubation
3 – 4 experts, required ≥ 2 to be in agreement for “anesthesia awareness”, “might have had anesthesia
awareness” or “did not have anesthesia awareness”
Statistics

Primary Outcome
Anticipated incidence of awareness was 1% for ETAG group, 0.1% for BIS-guided group
Aimed for a 0.9% difference with a one-tailed alpha of 0.05 and a power of 80% using Fisher’s exact test
Confidence intervals for absolute risk reduction calculated using Newcombe’s method without continuity
correction
Other comparisons – Variety of other statistical analyses inc. Χ2 test, Fisher’s exact test, unpaired t-test and
unpaired Mann-Whitney test

Results

2 cases definite “anesthesia awareness” in each group (i.e. 2 in BIS-guided and 2 in ETAG group)
Absolute difference between groups was 0% (95% CI -0.56 to 0.57%)
Additionally, 4 cases of “possible anesthesia awareness” in BIS-guided group and 1 case of possible anesthesia
awareness in ETAG group
BIS > 60 in 1 of the 4 cases of definite “anesthesia awareness” and 3 of the 9 cases of definite+possible “anesthesia
awareness”
MAC < 0.7 in 3 of the 4 cases of definite “anesthesia awareness” and 7 of the 9 cases of definite+possible
“anesthesia awareness”

Conclusions/Discussions

“We did not reproduce the results of previous studies that reported a lower incidence of anesthesia awareness
with BIS monitoring… Anesthesia awareness occurred even when BIS values and ETAG concentrations were within the
target ranges.” (pg. 1097)

Stated Limitations from the Study

Only focused on at-risk patients – ?Generalisability for entire adult population

Only focused on patients having volatile GA – Cautioned that use of TIVA is an additional risk factor for
awareness and recommended using BIS when using TIVA!
Diagnosis of awareness has a subjective element
Repeated questioning might induce false memories

Discussion from Journal Club Meeting (?Change of Practice)

What about BIS and TIVA?

Yes, big multi-centre RCT done in China has shown BIS-guided TIVA reduces risk of awareness vs. routine-
TIVA practice
Ref – Zhang et al. Bispectral index monitoring prevent awareness during total intravenous anesthesia: a
prospective, randomized, double-blinded, multi-center controlled trial. Chin Med J (Engl). 2011 Nov;
124(22):3664-9.
Re: B-Unaware Trial, any data for MAC < 0.7 but no awareness?
Data not explicitly available
What about Entropy (Kingston standard for brain monitoring)?
Far fewer studies, none of which have been RCTs in prevention of awareness

Summary by Dr J Kua. Journal Club Meeting 28 March 2019.

Image from https://commons.wikimedia.org/wiki/File:BIS_JPN.jpg

Published by kingstongasdocs

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May 14, 2019
Anaesthesia, awareness, Patient outcomes, Patient satisfaction, RCT

Anaesthesia, awareness, Bispectral index monitoring, Patient outcomes, Patient satisfaction, RCT, TIVA, Volatile
Anaesthesia

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