NCT04189861

Brief Summary

This research study is being done to determine if indices derived from monitoring brain wave activity while under general anesthesia will predict the likelihood of post-operative cognitive dysfunction in patients over 60 years old.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

December 3, 2019

Last Update Submit

January 13, 2026

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Postoperative Cognitive Decline

    The investigators will use a Composite Cognitive Change Score (between baseline and 3 months) to determine POCD

    3 months postoperatively

Secondary Outcomes (1)

  • Effective and Functional Connectivity

    Day of surgery

Other Outcomes (1)

  • Postoperative Delirium

    Postoperative days 2-7

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60-80 years of age who present for elective, non-cardiac surgical procedure requiring general anesthesia and an anticipated two-day or longer inpatient hospital stay

You may qualify if:

  • years of age who present for elective, non-cardiac surgical procedure requiring general anesthesia and an anticipated two-day or longer inpatient hospital stay
  • English as the native and primary language
  • Presence of an informant who has had weekly contact with the participant for at least the last year
  • Participant is capable of providing written informed consent.

You may not qualify if:

  • history of persistent and severe mental illness (e.g., schizophrenia, bipolar disorder)
  • neurological disorder (e.g., Parkinson's disease, epilepsy, stroke)
  • active substance use disorder as defined by the Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V)
  • history of prior diagnosis of learning disability per the DSM-V
  • estimated premorbid intellectual functioning below a scaled score of 70 based on the Test of Premorbid Functioning (TOPF)
  • severe visual or hearing impairments that prevent the participant from undergoing the neurocognitive assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (7)

  • Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.

    PMID: 19225398BACKGROUND

  • Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.

    PMID: 18156878BACKGROUND

  • Deiner S, Westlake B, Dutton RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr Soc. 2014 May;62(5):829-35. doi: 10.1111/jgs.12794. Epub 2014 Apr 14.

    PMID: 24731176BACKGROUND

  • Peters R. Ageing and the brain. Postgrad Med J. 2006 Feb;82(964):84-8. doi: 10.1136/pgmj.2005.036665.

    PMID: 16461469BACKGROUND

  • Morrison JH, Baxter MG. The ageing cortical synapse: hallmarks and implications for cognitive decline. Nat Rev Neurosci. 2012 Mar 7;13(4):240-50. doi: 10.1038/nrn3200.

    PMID: 22395804BACKGROUND

  • Brown EN, Purdon PL. The aging brain and anesthesia. Curr Opin Anaesthesiol. 2013 Aug;26(4):414-9. doi: 10.1097/ACO.0b013e328362d183.

    PMID: 23820102BACKGROUND

  • Purdon PL, Pavone KJ, Akeju O, Smith AC, Sampson AL, Lee J, Zhou DW, Solt K, Brown EN. The Ageing Brain: Age-dependent changes in the electroencephalogram during propofol and sevoflurane general anaesthesia. Br J Anaesth. 2015 Jul;115 Suppl 1(Suppl 1):i46-i57. doi: 10.1093/bja/aev213.

    PMID: 26174300BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • M. Dustin Boone, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Anesthesiology

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 6, 2019

Study Start

January 24, 2020

Primary Completion

November 11, 2025

Study Completion

November 11, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)