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Completed

NCT Number: NCT03067259

Post Operative 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, 1181, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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

Treatment and study plan

Exposure Group

Other

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

Primary outcomes

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

    Time frame: 1 year

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

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

    Time frame: 1 year

    Check the differences at 12 months after starting the study.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Acronym: POCD

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Mar 1, 2017
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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