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OpenTrials
Completed

NCT Number: NCT01743456

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted intra-operative depth of anaesthesia

Other

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

Primary outcomes

  1. Incidence of postoperative cognitive decline after bypass surgery

    Time frame: Six weeks after bypass surgery

Secondary outcomes

  1. Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery

    Time frame: Five days and one year postoperatively

  2. Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery

    Time frame: 5days, 6 weeks or 1 year postoperatively

  3. Postoperative Delirium

    Time frame: 3-5 days postoperatively

  4. Postoperative central nervous system and myocardial biochemical markers

    Time frame: up to 48 hours postoperatively

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 6, 2012
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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