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Post Operative Cognitive Dysfunction (POCD)

Primary Purpose

Postoperative Complications

Status

Completed

Phase

Not Applicable

Locations

Argentina

Study Type

Interventional

Intervention

Exposure Group

About this trial

This is an interventional health services research trial for Postoperative Complications focused on measuring eldery patients, cognitive impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control Group

Exposure Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

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

Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

Check the differences at 12 months after starting the study.

Secondary Outcome Measures

Full Information

NCT ID

NCT03067259

First Posted

February 22, 2017

Last Updated

February 2, 2023

Sponsor

Hospital Italiano de Buenos Aires

1. Study Identification

Unique Protocol Identification Number

NCT03067259

Brief Title

Post Operative Cognitive Dysfunction

Acronym

POCD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

February 20, 2017 (Actual)

Primary Completion Date

February 5, 2018 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Italiano de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

Keywords

eldery patients, cognitive impairment

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Arm Title

Exposure Group

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Exposure Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

Description

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

Time Frame

1 year

Title

Estimate the incidence of Post Operative Cognitive Dysfunction (POCD)

Description

Check the differences at 12 months after starting the study.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco FB Bonofiglio, PHD

Organizational Affiliation

Hospital Italiano de Buenos Aires

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Italiano de Buenos Aires

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

1181

Country

Argentina

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

13243706

Citation

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.

Results Reference

background

PubMed Identifier

9525362

Citation

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. Erratum In: Lancet 1998 Jun 6;351(9117):1742.

Results Reference

background

PubMed Identifier

12648190

Citation

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.

Results Reference

background

PubMed Identifier

17325499

Citation

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.

Results Reference

background

PubMed Identifier

18156877

Citation

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.

Results Reference

background

PubMed Identifier

16850780

Citation

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.

Results Reference

background

PubMed Identifier

22347689

Citation

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.

Results Reference

background

PubMed Identifier

21709661

Citation

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.

Results Reference

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Post Operative Cognitive Dysfunction

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