- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04215263
Risk Factors of POCD in General Anesthesia Patients Underwent Noncardiac and Non Neurological Procedures.
February 19, 2020 updated by: Aries Perdana, Indonesia University
Risk Factors of Post Operative Cognitive Dysfunction (POCD) in General Anesthesia Patients Underwent Noncardiac and Non Neurological Procedures.
The study was a prospective cohort study to assess the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was a prospective cohort study, assessing the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery.
The study used cognitive tests such as RAVLT, TMT, and Digit span tests.
POCD definition is reduction in postoperative cognitive function by as much as 20% at a minimum of 2 cognitive tests.
Study Type
Observational
Enrollment (Actual)
109
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 10430
- Indonesia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
Description
Inclusion Criteria:
- geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
- patient can do reading and writing
- patient can speak in Bahasa
- signing informed consent
Exclusion Criteria:
- patient with cognitive impairment or psychiatric disorder such as delirium, amnesia, anxiety disorder, or depression.
- patient under psychotropic drugs or narcotics.
- patient with history of brain tumor, head injury or motoric disturbance and disability that can disturbed neurocognitive test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatric patient underwent general anesthesia procedure
geriatric patients (≥60 years) ware assessed for cognitive impairment after general anesthesia for non-neurologic noncardiac surgery.
|
Patient was assessed using mini international neuropsychiatric interview
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini International Neuropsychiatric Interview
Time Frame: 7 days
|
Score was assessed using 6 forms
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aries Perdana, MD, Indonesia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493.
- Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
- Canet J, Raeder J, Rasmussen LS, Enlund M, Kuipers HM, Hanning CD, Jolles J, Korttila K, Siersma VD, Dodds C, Abildstrom H, Sneyd JR, Vila P, Johnson T, Munoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction after minor surgery in the elderly. Acta Anaesthesiol Scand. 2003 Nov;47(10):1204-10. doi: 10.1046/j.1399-6576.2003.00238.x.
- van Harten AE, Scheeren TW, Absalom AR. A review of postoperative cognitive dysfunction and neuroinflammation associated with cardiac surgery and anaesthesia. Anaesthesia. 2012 Mar;67(3):280-93. doi: 10.1111/j.1365-2044.2011.07008.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
July 5, 2019
Study Completion (Actual)
July 5, 2019
Study Registration Dates
First Submitted
December 30, 2019
First Submitted That Met QC Criteria
December 30, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 19, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IndonesiaUAnes 044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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