Cardiac Bypass Surgery in Adult Patients 65 Years and OlderNCT01743456
Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery
A study testing Targeted intra-operative depth of anaesthesia in people with Cardiac Bypass Surgery in Adult Patients 65 Years and Older and Postoperative Cognitive Dysfunction, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiac Bypass Surgery in Adult Patients 65 Years and Older, Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Targeted intra-operative depth of anaesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients undergoing elective coronary artery bypass graft surgery
- patients at 65 years of age and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, Denmark Hill, SE5 9RS
About this study
Official title: Effect of Depth of Anaesthesia on Postoperative Cognitive Decline in Patients Undergoing Coronary Artery Bypass Graft Surgery - a Prospectively Randomized Controlled Study
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).
Read more
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
- Being tested
- Targeted intra-operative depth of anaesthesia
- Keywords
- Postoperative cognitive dysfunction, Coronary artery bypass graft surgery, Postoperative cognitive improvement, Postoperative delirium
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted intra-operative depth of anaesthesiaOther
The intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Current practice (BIS and rSO2 blinded) | No intervention | Not described |
| Targeted intra-operative depth of anaesthesia | Experimental | Not described Receives: Other: Targeted intra-operative depth of anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive decline after bypass surgery
Measured: Six weeks after bypass surgery
Secondary outcomes (4)
Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery
Measured: Five days and one year postoperatively
Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery
Measured: 5days, 6 weeks or 1 year postoperatively
Postoperative Delirium
Measured: 3-5 days postoperatively
Postoperative central nervous system and myocardial biochemical markers
Measured: up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Bypass Surgery in Adult Patients 65 Years and OlderStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Green, FRCA, MBA, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743456
- Sponsor's protocol ID
- KHC11-001
- Status last verified
- Jan 2013
- First submitted
- 4 Dec 2012
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22719840
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Depth of Anaesthesia on Postoperative Cognitive Decline in Patients Undergoing Coronary Artery Bypass Graft Surgery - a Prospectively Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01743456
- Acronym / sponsor ID
- KHC11-001
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current practice (BIS and rSO2 blinded) | No intervention | – |
| Targeted intra-operative depth of anaesthesia | Experimental | Other: Targeted intra-operative depth of anaesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patients undergoing elective coronary artery bypass graft surgery
- patients at 65 years of age and older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted intra-operative depth of anaesthesiaThe intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively. | Other | Targeted intra-operative depth of anaesthesia |
Primary outcome
Incidence of postoperative cognitive decline after bypass surgery
Time frame: Six weeks after bypass surgery
4 secondary outcomes
Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery
Time frame: Five days and one year postoperatively
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
Postoperative Delirium
Time frame: 3-5 days postoperatively
Postoperative central nervous system and myocardial biochemical markers
Time frame: up to 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Background: PubMed 22719840Ballard 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Green, FRCA, MBA principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted intra-operative depth of anaesthesia in people with Cardiac Bypass Surgery in Adult Patients 65 Years and Older and Postoperative Cognitive Dysfunction, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cognitive decline after bypass surgery (time frame: Six weeks after bypass surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.