Post Operative Cognitive Dysfunction

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Other: Exposure Group

• Registration Number: NCT03067259
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Primary Completion: 2018-02-05
• Study Completion: 2022-03-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)	1 year	Check the differences at 12 months after starting the study.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina