Optimizing Postoperative Cognition the Elderly

NCT ID: NCT02650687

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-11-14

Brief Summary

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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

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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

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Postoperative Cognitive Dysfunction POCD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elective Non Cardiac Surgical Patients

65 years of age and older

Processed EEG

Intervention Type PROCEDURE

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

Interventions

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Processed EEG

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

Intervention Type PROCEDURE

Other Intervention Names

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brain waves

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacie Deiner, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34862586 (View on PubMed)

Cooter 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.

Reference Type DERIVED
PMID: 34252066 (View on PubMed)

Esses 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.

Reference Type DERIVED
PMID: 31061107 (View on PubMed)

Deiner 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.

Reference Type DERIVED
PMID: 31003631 (View on PubMed)

Other Identifiers

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1K23AG048332-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 13-1692

Identifier Type: -

Identifier Source: org_study_id

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