Optimizing Postoperative Cognition the Elderly

NCT02650687 | Completed DMC

• 2 other identifiers: GCO 13-16921K23AG048332-01A1
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction; POCD

Keywords

Postoperative Cognitive Dysfunction; Elderly, geriatric; Anesthesia; Anesthetic depth; Bispectral index monitor; Function; Recovery after surgery; Surgery

Outcome Measures

Primary Outcomes (1)

• UDS battery

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

  3 months

Secondary Outcomes (10)

• Processed EEG

  1 year

• CAM-ICU

  baseline

• CAM-ICU

  Day 1

• CAM-ICU

  Day 3

• CAM-ICU

  1 week

Study Arms (1)

Elective Non Cardiac Surgical Patients

65 years of age and older

Procedure: Processed EEG

Interventions

Processed EEG PROCEDURE

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

Also known as: brain waves

Elective Non Cardiac Surgical Patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• years of age and older
• having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (4)

• 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.

  PMID: 34862586 DERIVED

• 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.

  PMID: 34252066 DERIVED

• 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.

  PMID: 31061107 DERIVED

• 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.

  PMID: 31003631 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Brain Waves

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electroencephalography; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stacie Deiner, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 8, 2016
• Study Start: October 1, 2015
• Primary Completion: February 25, 2019
• Study Completion: November 14, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

US (1)