Optimizing Postoperative Cognition the Elderly

Completed

• Conditions: POCD; Postoperative Cognitive Dysfunction
• Interventions: Procedure: Processed EEG

• Registration Number: NCT02650687
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Primary Completion: 2019-02-25
• Study Completion: 2019-11-14
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective Non Cardiac Surgical Patients	Processed EEG	65 years of age and older

Primary Outcome Measures

Name	Time	Method
UDS battery	3 months	Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States