We are performing a large randomised trial of *deep* versus *light* anaesthesia to definitively answer the question of whether anaesthetic depth alters perioperative outcome. Elderly patients undergoing major surgery will be randomised to an…
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Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary hypothesis
Light general anaesthesia (BIS = 50) is associated with decreased all cause
mortality compared with deep general anaesthesia (BIS = 35) one year after
major surgery in elderly patients.
Secondary outcome
Secondary hypotheses
Light general anaesthesia (BIS = 50) is associated with decreased incidences of
MI, cardiac arrest, PE, stroke, sepsis and surgical site infection compared
with deep general anaesthesia (BIS = 35) at 30 days and one year after major
surgery in elderly patients.
Light general anaesthesia (BIS = 50) is associated with decreased incidences of
a composite endpoint of MI, cardiac arrest, PE and stroke compared with deep
general anaesthesia (BIS = 35) at 30 days and one year after major surgery in
elderly patients.
Light general anaesthesia (BIS = 50) is associated with decreased cancer
recurrence compared with deep general anaesthesia (BIS = 35) one year after
major surgery in elderly patients.
Light general anaesthesia (BIS=50) is associated with an increased incidence of
persistent postoperative pain compared with deep anaesthesia (BIS=35) at 30
days and one year after surgery in elderly patients.
Light anaesthesia (BIS = 50) is associated with increased disability-free
survival compared with deep general anaesthesia (BIS = 35) one year after major
surgery in elderly patients.
Safety and quality hypotheses
Light general anaesthesia (BIS = 50) is associated with improved early quality
of recovery compared with deep general anaesthesia (BIS = 35) after major
surgery in elderly patients.
Light general anaesthesia (BIS = 50) does not increase the incidence of
awareness compared with deep general anaesthesia (BIS = 35) after major surgery
in elderly patients.
Background summary
Monitors that use the electroencephalogram (EEG) to assess anesthetic depth in
patients undergoing surgery are now widely available. General anesthesia that
is performed without depth of anesthesia monitoring, tends to be relatively
deep to ensure a lack of awareness. Five of six recent observational studies
have shown that deep anesthesia may be associated with an increase in mortality
(up to 20%) in moderate or high risk patients undergoing major surgery who
receive relatively deep anesthesia, although it is difficult to exclude the
effects of other factors such as blood pressure. This also needs to be balanced
against a possible increase in the risk of awareness if patients are given
lower doses of anesthetic drugs. It is largely unknown how anesthetic depth
influences these and other perioperative outcomes.
Study objective
We are performing a large randomised trial of *deep* versus *light* anaesthesia
to definitively answer the question of whether anaesthetic depth alters
perioperative outcome. Elderly patients undergoing major surgery will be
randomised to an anaesthetic targeting either BIS=35 or BIS=50 for the deep and
light groups respectively. The primary outcome variable will be all-cause
mortality at one year and secondary outcomes will be MI, cardiac arrest, PE,
stroke, sepsis, surgical site infection, ICU stay, hospital stay, awareness,
WHODAS score, persistent postoperative pain and cancer recurrence.
Study design
International multicentre, prospective, randomised, double blind (subjects,
investigators and outcomes assessors), active control, parallel assessment,
intention to treat, safety and efficacy study.
Study burden and risks
The burden for patients who participate in this study is limited to completing
several short questionnaires during the follow-up period of the study. There
are no known additional risks from participating in this study beyond those of
general anaesthesia. Currently there are no guidelines on the appropriate depth
of anaesthesia to choose during operations. The two depths chosen in this study
are within the common range used for general anaesthesia. They are both deeper
than the level associated with awareness under anaesthesia. An individualised
mean arterial blood pressure target range appropriate for the patient being
studied will be set by the anaesthetist before randomisation, which is
according to routine care practice.
There are no expected individual benefits for the study participants.
Wellington Road 2
Clayton, VIC 3800
AU
Wellington Road 2
Clayton, VIC 3800
AU
Listed location countries
Age
Inclusion criteria
*60 years
ASA physical status 3 or 4
Surgery lasting *2 hours
Post-op hospital stay *2 nights
General anaesthesia with or without major regional block
Able to monitor BIS
Exclusion criteria
Unable to monitor BIS (e.g. cranial or intracranial surgery)
Unable to consent
Surgery with *wake-up* test
Propofol infusion for part or all of maintenance of anaesthesia (*total intravenous anaesthesia*), Previous enrolment in Balanced study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ACTRN12612000632897 |
| CCMO | NL51677.041.15 |