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Postoperative ComplicationsPOCDNCT03067259

Post Operative Cognitive Dysfunction

A study testing Exposure Group in people with Postoperative Complications, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Postoperative Complications
What is being tested?
Exposure Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteArgentina
Study dates
20 Feb 2017to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Italiano de Buenos Aires

    Buenos Aires, 1181

Other trials in Argentina

About this study

Official title: Impact of Anesthesia Surgical Procedure on the Development of Long-term Cognitive Dysfunction

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.

Read the detailed description

Prospective Study The objective of this study will be to estimate the incidence of Post Operative Cognitive Dysfunction (POCD) 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.

The population of the present study will be constituted by patients belonging to the HIBA Health Plan. It comprises patients who will not undergo any surgical / anesthetic act (Control Group) and those who will undergo sedation for diagnostic procedure or some surgical / anesthetic process (Exposure Group).

All patients will be tested, the day of signing the Informed Consent (IC), which will serve as an exclusion criterion.

Patients in the Exposure Group who signed the consent will be evaluated on five occasions: up to the day before the surgical / anesthetic act, on the day of the surgical / anesthetic event, 7 days (CAM - If the patient is hospitalized this test will do the test personally if the patient is discharged, the test will be done by telephone), 3 months later and a year after the procedure (for the latter two patients will be asked to attend the Hospital in time). Trained and trained personnel will be in charge of taking the test (which last approximately 1 hour). The battery of tests (detailed below) aims to determine if there is a cognitive decline, to estimate and compare it among the participants of this study.

Patients in the control group will be evaluated on 2 occasions only, a first evaluation on the day the patient and the researchers arrange and then, 12 months from that date.

Being tested
Exposure Group
Keywords
eldery patients, cognitive impairment
Medical subject headings
Postoperative Complications, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure GroupOther

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

Study groups in NCT03067259
Study groupRoleWhat they receive
Control GroupNo interventionIt comprises patients who will not undergo any surgical / anesthetic act
Exposure GroupOtherIt comprises those patients that will undergo sedation for diagnostic procedure or some surgical / anesthetic process
Receives: Other: Exposure Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

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

    Measured: 1 year

  2. Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

    Check the differences at 12 months after starting the study.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start20 Feb 2017
  3. Primary completion5 Feb 2018
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067259
Sponsor's protocol ID
2813
Acronym
POCD
Status last verified
Feb 2023
First submitted
22 Feb 2017
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 13243706

  • 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.

    PubMed 9525362

  • 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.

    PubMed 12648190

  • 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.

    PubMed 17325499

  • 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.

    PubMed 18156877

  • 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.

    PubMed 16850780

  • 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.

    PubMed 22347689

  • 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.

    PubMed 21709661

Questions about this trial

What is this clinical trial studying?

A study testing Exposure Group in people with Postoperative Complications, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the incidence of Post Operative Cognitive Dysfunction (POCD) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067259, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.

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