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

Effect of Depth of Anaesthesia on Postoperative Cognitive Decline in Patients Undergoing Coronary Artery Bypass Graft Surgery - a Prospectively Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743456
Enrollment
88
Registered
2012-12-06
Start date
2014-01-31
Completion date
2017-01-31
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Postoperative cognitive dysfunction, Coronary artery bypass graft surgery, Postoperative cognitive improvement, Postoperative delirium

Brief summary

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).

Interventions

OTHERTargeted intra-operative depth of anaesthesia

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

Sponsors

King's College Hospital NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative cognitive decline after bypass surgerySix weeks after bypass surgery

Secondary

MeasureTime frame
Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgeryFive days and one year postoperatively
Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery5days, 6 weeks or 1 year postoperatively
Postoperative Delirium3-5 days postoperatively
Postoperative central nervous system and myocardial biochemical markersup to 48 hours postoperatively

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026