NCT03067259

Brief Summary

The objective of this study will be to estimate the incidence of postoperative cognitive dysfunction (DCPO) in patients over 65 years of age, undergoing surgical / anesthetic procedures and in patients who will not undergo surgical / anesthetic. The patients will be taken from the Hospital Italiano de Buenos Aires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

February 20, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 22, 2017

Last Update Submit

February 2, 2023

Conditions

Postoperative Complications

Keywords

eldery patientscognitive impairment

Outcome Measures

Primary Outcomes (2)

  • Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

    We will measure the cognitive impairment using a battery of cognitive tests .

    1 year

  • Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

    Check the differences at 12 months after starting the study.

    1 year

Study Arms (2)

Control Group

NO INTERVENTION

It comprises patients who will not undergo any surgical / anesthetic act

Exposure Group

OTHER

It comprises those patients that will undergo sedation for diagnostic procedure or some surgical / anesthetic process

Other: Exposure Group

Interventions

Exposure GroupOTHER

Surgeries of high or low impact. They could be local , regional o general anesthesia; sedation or a combination of both.

Exposure Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • or surgical / anesthetic and sedation.
  • Patients who have not been exposed in the last 12 months to any of the cases mentioned above.
  • Patients with scheduled surgeries will be included, both in the outpatient clinic and with requirements for hospitalization in the floor or in closed units (ICU, UC, etc.), and patients with diagnostic studies or therapeutic procedures requiring anesthesia for their performance by the other.
  • Patients will be included with absence of anesthetic or surgical / anesthetic act and sedation in the last 12 months.
  • Patients with complete primary schooling (6 years) will be included.

You may not qualify if:

  • Negative to participate or manage Informed Consent
  • MoCa (≤ 26)
  • Previous diagnosis of dementia
  • Psychosis
  • Depression. (GDS Yesavage\> 5)
  • Toxic Substance abuse of Alcohol according to DSM4 Psychoactive Substances.
  • Use of Illicit drug
  • The presence of any congenital or acquired disease or injury that could generate cognitive deficit. (Whether psychiatric, neurological, or metabolic)
  • Previous neurosurgery.
  • Language barriers.
  • Decreased marked visual or auditory acuity that enable from performing the study tests.
  • Patients receiving antipsychotics, opioids, anticholinergics or patients who may have varied the benzodiazepines doze or other psychoactive drugs in the last 30 days.
  • Patient with cancer disease and life expectancy less than 1 year ( patients will be evaluated from the medical point of view from the records of clinical history according to tumor type, extent,etc.)
  • Patients undergoing emergency surgery.
  • Patients who have received anesthesia in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1181, Argentina

Location

Related Publications (8)

  • BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. doi: 10.1016/s0140-6736(55)92689-1. No abstract available.

    PMID: 13243706BACKGROUND

  • Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.

    PMID: 9525362BACKGROUND

  • Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.

    PMID: 12648190BACKGROUND

  • Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Hyde TF, Reddy DM, Hudetz AG, Warltier DC. Postoperative cognitive dysfunction in older patients with a history of alcohol abuse. Anesthesiology. 2007 Mar;106(3):423-30. doi: 10.1097/00000542-200703000-00005.

    PMID: 17325499BACKGROUND

  • Price CC, Garvan CW, Monk TG. Type and severity of cognitive decline in older adults after noncardiac surgery. Anesthesiology. 2008 Jan;108(1):8-17. doi: 10.1097/01.anes.0000296072.02527.18.

    PMID: 18156877BACKGROUND

  • Rasmussen LS. Postoperative cognitive dysfunction: incidence and prevention. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):315-30. doi: 10.1016/j.bpa.2005.10.011.

    PMID: 16850780BACKGROUND

  • Spiegel DR, Chen V. A case of postoperative cognitive decline, with a highly elevated C- reactive protein, status post left ventricular assist device insertion: a review of the neuroinflammatory hypothesis of delirium. Innov Clin Neurosci. 2012 Jan;9(1):35-41.

    PMID: 22347689BACKGROUND

  • Krenk L, Rasmussen LS. Postoperative delirium and postoperative cognitive dysfunction in the elderly - what are the differences? Minerva Anestesiol. 2011 Jul;77(7):742-9.

    PMID: 21709661BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Francisco FB Bonofiglio, PHD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Doctor

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 1, 2017

Study Start

February 20, 2017

Primary Completion

February 5, 2018

Study Completion

March 1, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)