Optimizing Postoperative Cognition the Elderly

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Optimizing Postoperative Cognition the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650687
• Other study ID #: GCO 13-1692
• Secondary ID: 1K23AG048332-01A
• Status: Completed
• Start date: October 2015
• Est. completion date: November 14, 2019

Study information

• Verified date: March 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: November 14, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• POCD
• Postoperative Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UDS battery	Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition	3 months
Secondary	Processed EEG	Processed EEG will be measured using the Bispectral Index (BIS) monitor.	1 year
Secondary	CAM-ICU	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.	baseline
Secondary	CAM-ICU	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.	Day 1
Secondary	CAM-ICU	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.	Day 3
Secondary	CAM-ICU	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.	1 week
Secondary	PQRS	Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)	baseline
Secondary	PQRS	Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)	Day 1
Secondary	PQRS	Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)	Day 3
Secondary	PQRS	Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)	1 week
Secondary	UDS battery	Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition	1 year