Clinical trial NCT02650687: Optimizing Postoperative Cognition the Elderly
Official title: Optimizing Postoperative Cognition the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
POCD
Keywords: Postoperative Cognitive Dysfunction
Elderly, geriatric
Anesthesia
Anesthetic depth
Bispectral index monitor
Function
Recovery after surgery
Surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-01-08
Enrollment: 178
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: UDS battery
timeFrame: 3 months
Secondary outcomes:
measure: Processed EEG
timeFrame: 1 year
measure: CAM-ICU
timeFrame: baseline
measure: CAM-ICU
timeFrame: Day 1
measure: CAM-ICU
timeFrame: Day 3
measure: CAM-ICU
timeFrame: 1 week
measure: PQRS
timeFrame: baseline
measure: PQRS
timeFrame: Day 1
measure: PQRS
timeFrame: Day 3
measure: PQRS
timeFrame: 1 week
measure: UDS battery
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Stacie Deiner, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.