Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery
Primary Purpose
Cardiac Bypass Surgery in Adult Patients 65 Years and Older, Postoperative Cognitive Dysfunction, Postoperative Delirium
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Targeted intra-operative depth of anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Bypass Surgery in Adult Patients 65 Years and Older focused on measuring Postoperative cognitive dysfunction, Coronary artery bypass graft surgery, Postoperative cognitive improvement, Postoperative delirium
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
Sites / Locations
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Current practice (BIS and rSO2 blinded)
Targeted intra-operative depth of anaesthesia
Arm Description
Outcomes
Primary Outcome Measures
Incidence of postoperative cognitive decline after bypass surgery
Secondary Outcome Measures
Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery
Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery
Postoperative Delirium
Postoperative central nervous system and myocardial biochemical markers
Full Information
NCT ID
NCT01743456
First Posted
December 4, 2012
Last Updated
October 21, 2019
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01743456
Brief Title
Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery
Official Title
Effect of Depth of Anaesthesia on Postoperative Cognitive Decline in Patients Undergoing Coronary Artery Bypass Graft Surgery - a Prospectively Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current practice (BIS and rSO2 blinded)
Arm Type
No Intervention
Arm Title
Targeted intra-operative depth of anaesthesia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Targeted intra-operative depth of anaesthesia
Intervention Description
The intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.
Primary Outcome Measure Information:
Title
Incidence of postoperative cognitive decline after bypass surgery
Time Frame
Six weeks after bypass surgery
Secondary Outcome Measure Information:
Title
Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery
Time Frame
Five days and one year postoperatively
Title
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
Title
Postoperative Delirium
Time Frame
3-5 days postoperatively
Title
Postoperative central nervous system and myocardial biochemical markers
Time Frame
up to 48 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Green, FRCA, MBA
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
Denmark Hill
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22719840
Citation
Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Prophet N, Purushothaman B, Green D. Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial. PLoS One. 2012;7(6):e37410. doi: 10.1371/journal.pone.0037410. Epub 2012 Jun 15. Erratum In: PLoS One. 2012;7(9). doi:10.1371/annotation/1cc38e55-23e8-44a5-ac2b-43c7b2a880f9. Amaoko, Derek [corrected to Amoako, Derek]. PLoS One. 2013;8(9). doi:10.1371/annotation/c0569644-bea1-4c38-af9a-75d1168e3142.
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Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery
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