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Optimizing Postoperative Cognition the Elderly

Optimizing Postoperative Cognition the Elderly

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02650687
Enrollment
178
Registered
2016-01-08
Start date
2015-10-31
Completion date
2019-11-14
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

POCD, Postoperative Cognitive Dysfunction

Keywords

Postoperative Cognitive Dysfunction, Elderly, geriatric, Anesthesia, Anesthetic depth, Bispectral index monitor, Function, Recovery after surgery, Surgery

Brief 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. 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.

Interventions

PROCEDUREProcessed EEG

In the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 65 years of age and older * having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
UDS battery3 monthsPostoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

Secondary

MeasureTime frameDescription
Processed EEG1 yearProcessed EEG will be measured using the Bispectral Index (BIS) monitor.
CAM-ICUbaselineThe 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.
PQRSbaselineShort -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
UDS battery1 yearPostoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026