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

NCT01743456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-10-22

No results posted yet for this study

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).

Conditions

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • David Green, FRCA, MBA · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01743456 on ClinicalTrials.gov