Clinical Trials Directory

Trials / Completed

CompletedNCT01743456

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
Phase
N/A
Study type
Interventional
Enrollment
88 (actual)
Sponsor
King's College Hospital NHS Trust · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERTargeted intra-operative depth of anaesthesiaThe intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.

Timeline

Start date
2014-01-01
Primary completion
2016-01-01
Completion
2017-01-01
First posted
2012-12-06
Last updated
2019-10-22

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01743456. Inclusion in this directory is not an endorsement.