Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-01-31

Brief Summary

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Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with increased morbidity and mortality. The pathophysiology of POCD is only poorly understood. Causes include hypoperfusion, microemboli and the systemic inflammatory response, which result in a reduction of cerebral oxygen delivery.

Cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen saturation (rSO2).

The bispectral index (BIS) of the electroencephalogram is widely known to measure depth of anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely low.

The investigators demonstrated recently that inappropriately high levels of anaesthesia may be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has an effect on postoperative cognitive function in patients undergoing cardiac surgery is unknown.

The investigators hypothesize that the incidence of POCD in elderly patients (\> 65 years old) at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2 (interventions when rSO2 drops below 15% of baseline reading) when compared with current practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and blinded rSO2 measurements).

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Detailed Description

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Conditions

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Cardiac Bypass Surgery in Adult Patients 65 Years and Older Postoperative Cognitive Dysfunction Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Current practice (BIS and rSO2 blinded)

Group Type NO_INTERVENTION

No interventions assigned to this group

Targeted intra-operative depth of anaesthesia

Group Type EXPERIMENTAL

Targeted intra-operative depth of anaesthesia

Intervention Type OTHER

The intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.

Interventions

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Targeted intra-operative depth of anaesthesia

The intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective coronary artery bypass graft surgery
* patients at 65 years of age and older

Exclusion Criteria

* diseases of the central nervous system including dementia
* inadequate knowledge of English
* a current or past psychiatric illness
* current use of tranquilizers or antidepressants
* severe visual, auditory, or motor handicap

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No