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Clinical Trials/NCT02650687
NCT02650687
Completed
Not Applicable

Optimizing Postoperative Cognition the Elderly

Icahn School of Medicine at Mount Sinai1 site in 1 country178 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Cognitive Dysfunction
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
178
Locations
1
Primary Endpoint
UDS battery
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
November 14, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

UDS battery

Time Frame: 3 months

Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

Secondary Outcomes

  • Processed EEG(1 year)
  • CAM-ICU(1 week)
  • PQRS(1 week)
  • UDS battery(1 year)

Study Sites (1)

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