Postoperative Cognitive DysfunctionNCT02650687
Optimizing Postoperative Cognition the Elderly
An observational study of Postoperative Cognitive Dysfunction and POCD, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, POCD
- What is being tested?
- Processed EEG
- Type of treatment
- Surgery or procedure
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 14 Nov 2019
- Phase
- Observational
- 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
Study population: Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai.
Who may be able to join
- 65 years of age and older
- having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay
Who cannot join
- previous diagnosis of dementia, stroke, cardiac or intracranial surgery
- inability to consent or communicate in English or Spanish
- major uncorrected hearing or vision deficit, Parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. The hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.
Read the detailed description
Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai. After informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. In the recovery room the Post Anesthesia Recovery Scale (PQRS), and CAM-ICU delirium screening will be administered. Immediate recovery will be recorded using the Postoperative Recovery Scale (PQRS) on postoperative day 1 and 3, and 1 week.
Longterm functional recovery will be measured with the Alzheimer's Disease Research Center (ADRC) Instrumental Activities for Daily Living (IADL-24). Postsurgical complications will be recorded including unplanned ICU admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. The full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.
- Conditions
- Postoperative Cognitive Dysfunction, POCD
- Being tested
- Processed EEG
- Keywords
- Postoperative Cognitive Dysfunction, Elderly, geriatric, Anesthesia, Anesthetic depth, Bispectral index monitor, Function, Recovery after surgery, Surgery
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed EEGProcedure or surgery
Also called brain waves
In the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Elective Non Cardiac Surgical Patients | 65 years of age and older Receives: Procedure: Processed EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDS battery
Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition
Measured: 3 months
Secondary outcomes (10)
Processed EEG
Processed EEG will be measured using the Bispectral Index (BIS) monitor.
Measured: 1 year
CAM-ICU
The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.
Measured: baseline
CAM-ICU
The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.
Measured: Day 1
CAM-ICU
The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.
Measured: Day 3
CAM-ICU
The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.
Measured: 1 week
PQRS
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
Measured: baseline
PQRS
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
Measured: Day 1
PQRS
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
Measured: Day 3
PQRS
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
Measured: 1 week
UDS battery
Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startOct 2015
- Primary completion25 Feb 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stacie Deiner, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650687
- Sponsor's protocol ID
- GCO 13-1692
- Other IDs
- 1K23AG048332-01A1
- Status last verified
- Mar 2020
- First submitted
- 23 Dec 2015
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dustin Boone M, Lin HM, Liu X, Kim J, Sano M, Baxter MG, Sieber FE, Deiner SG. Processed intraoperative burst suppression and postoperative cognitive dysfunction in a cohort of older noncardiac surgery patients. J Clin Monit Comput. 2022 Oct;36(5):1433-1440. doi: 10.1007/s10877-021-00783-0. Epub 2021 Dec 3.
PubMed 34862586Cooter Wright M, Bunning T, Eleswarpu SS, Heflin MT, McDonald SR, Lagoo-Deenadalayan S, Whitson HE, Martinez-Camblor P, Deiner SG, Berger M. A Processed Electroencephalogram-Based Brain Anesthetic Resistance Index Is Associated With Postoperative Delirium in Older Adults: A Dual Center Study. Anesth Analg. 2022 Jan 1;134(1):149-158. doi: 10.1213/ANE.0000000000005660.
PubMed 34252066Esses GJ, Liu X, Lin HM, Khelemsky Y, Deiner S. Preoperative frailty and its association with postsurgical pain in an older patient cohort. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100247. doi: 10.1136/rapm-2018-100247. Online ahead of print.
PubMed 31061107Deiner S, Liu X, Lin HM, Sieber F, Boockvar K, Sano M, Baxter MG. Subjective cognitive complaints in patients undergoing major non-cardiac surgery: a prospective single centre cohort trial. Br J Anaesth. 2019 Jun;122(6):742-750. doi: 10.1016/j.bja.2019.02.027. Epub 2019 Apr 17.
PubMed 31003631
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Postoperative Cognition the Elderly
- ClinicalTrials.gov ID
- NCT02650687
- Acronym / sponsor ID
- GCO 13-1692
- Conditions
- Postoperative Cognitive Dysfunction, POCD
- Keywords
- Postoperative Cognitive Dysfunction, Elderly, geriatric, Anesthesia, Anesthetic depth, Bispectral index monitor, Function, Recovery after surgery, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2015
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 8 Jan 2016 (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.
This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. The hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.
Detailed description
Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai. After informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. In the recovery room the Post Anesthesia Recovery Scale (PQRS), and CAM-ICU delirium screening will be administered. Immediate recovery will be recorded using the Postoperative Recovery Scale (PQRS) on postoperative day 1 and 3, and 1 week.
Longterm functional recovery will be measured with the Alzheimer's Disease Research Center (ADRC) Instrumental Activities for Daily Living (IADL-24). Postsurgical complications will be recorded including unplanned ICU admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. The full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Non Cardiac Surgical Patients | – | Procedure: Processed EEG65 years of age and older |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai.
Key inclusion criteria (2 listed)
- 65 years of age and older
- having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay
Key exclusion criteria (3 listed)
- previous diagnosis of dementia, stroke, cardiac or intracranial surgery
- inability to consent or communicate in English or Spanish
- major uncorrected hearing or vision deficit, Parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.
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 |
|---|---|---|
| Processed EEGAlso: brain wavesIn the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care. | Procedure or surgery | Elective Non Cardiac Surgical Patients |
Primary outcome
UDS battery
Time frame: 3 months
Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition
10 secondary outcomes
Processed EEG
Time frame: 1 year
CAM-ICU
Time frame: baseline
CAM-ICU
Time frame: Day 1
CAM-ICU
Time frame: Day 3
CAM-ICU
Time frame: 1 week
PQRS
Time frame: baseline
PQRS
Time frame: Day 1
PQRS
Time frame: Day 3
PQRS
Time frame: 1 week
UDS battery
Time frame: 1 year
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 23 Mar 2020.
- Derived from this study: PubMed 34862586Dustin Boone M, Lin HM, Liu X, Kim J, Sano M, Baxter MG, Sieber FE, Deiner SG. Processed intraoperative burst suppression and postoperative cognitive dysfunction in a cohort of older noncardiac surgery patients. J Clin Monit Comput. 2022 Oct;36(5):1433-1440. doi: 10.1007/s10877-021-00783-0. Epub 2021 Dec 3.
- Derived from this study: PubMed 34252066Cooter Wright M, Bunning T, Eleswarpu SS, Heflin MT, McDonald SR, Lagoo-Deenadalayan S, Whitson HE, Martinez-Camblor P, Deiner SG, Berger M. A Processed Electroencephalogram-Based Brain Anesthetic Resistance Index Is Associated With Postoperative Delirium in Older Adults: A Dual Center Study. Anesth Analg. 2022 Jan 1;134(1):149-158. doi: 10.1213/ANE.0000000000005660.
- Derived from this study: PubMed 31061107Esses GJ, Liu X, Lin HM, Khelemsky Y, Deiner S. Preoperative frailty and its association with postsurgical pain in an older patient cohort. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100247. doi: 10.1136/rapm-2018-100247. Online ahead of print.
- Derived from this study: PubMed 31003631Deiner S, Liu X, Lin HM, Sieber F, Boockvar K, Sano M, Baxter MG. Subjective cognitive complaints in patients undergoing major non-cardiac surgery: a prospective single centre cohort trial. Br J Anaesth. 2019 Jun;122(6):742-750. doi: 10.1016/j.bja.2019.02.027. Epub 2019 Apr 17.
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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.
Stacie Deiner, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and POCD, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 3 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 23 Mar 2020. 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 States. 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?
UDS battery (time frame: 3 months). 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 NCT02650687, which also lists 4 linked publications.
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 23 Mar 2020.