Optimizing Postoperative Cognition the Elderly

March 20, 2020 updated by: Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elective Non Cardiac Surgical Patients
65 years of age and older
Procedure: Processed EEG
In the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care.
Other Names:
  • brain waves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UDS battery
Time Frame: 3 months
Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Processed EEG
Time Frame: 1 year
Processed EEG will be measured using the Bispectral Index (BIS) monitor.
1 year
CAM-ICU
Time Frame: baseline
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.
baseline
CAM-ICU
Time Frame: Day 1
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.
Day 1
CAM-ICU
Time Frame: Day 3
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.
Day 3
CAM-ICU
Time Frame: 1 week
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.
1 week
PQRS
Time Frame: baseline
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
baseline
PQRS
Time Frame: Day 1
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
Day 1
PQRS
Time Frame: Day 3
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
Day 3
PQRS
Time Frame: 1 week
Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)
1 week
UDS battery
Time Frame: 1 year
Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Stacie Deiner, MD, MS, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

February 25, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 13-1692
  • 1K23AG048332-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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