Clinical Trials Directory

Trials / Completed

CompletedNCT02650687

Optimizing Postoperative Cognition the Elderly

Status
Completed
Phase
Study type
Observational
Enrollment
178 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2015-10-01
Primary completion
2019-02-25
Completion
2019-11-14
First posted
2016-01-08
Last updated
2020-03-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02650687. Inclusion in this directory is not an endorsement.