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Clinical Trials/NCT03067259
NCT03067259
Completed
N/A

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

Hospital Italiano de Buenos Aires1 site in 1 country100 target enrollmentFebruary 20, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
Hospital Italiano de Buenos Aires
Enrollment
100
Locations
1
Primary Endpoint
Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2017
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

FRANCISCO CARLOS BONOFIGLIO

Anesthesiology Doctor

Hospital Italiano de Buenos Aires

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

Time Frame: 1 year

Check the differences at 12 months after starting the study.

Study Sites (1)

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