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Clinical Trials/NCT01743456
NCT01743456
Completed
N/A

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

King's College Hospital NHS Trust1 site in 1 country88 target enrollmentJanuary 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Bypass Surgery in Adult Patients 65 Years and Older
Sponsor
King's College Hospital NHS Trust
Enrollment
88
Locations
1
Primary Endpoint
Incidence of postoperative cognitive decline after bypass surgery
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
January 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
King's College Hospital NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of postoperative cognitive decline after bypass surgery

Time Frame: Six weeks after bypass surgery

Secondary Outcomes

  • Postoperative Delirium(3-5 days postoperatively)
  • Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery(5days, 6 weeks or 1 year postoperatively)
  • Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery(Five days and one year postoperatively)
  • Postoperative central nervous system and myocardial biochemical markers(up to 48 hours postoperatively)

Study Sites (1)

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