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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04215263
Other study ID # IndonesiaUAnes 044
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date July 5, 2019

Study information

Verified date February 2020
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date July 5, 2019
Est. primary completion date July 5, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionaire
Patient was assessed using mini international neuropsychiatric interview

Locations

Country Name City State
Indonesia Indonesia University Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. — View Citation

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, Muñoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction a — View Citation

Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119. Review. — View Citation

Strøm C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1:35-44. doi: 10.1111/anae.12493. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mini International Neuropsychiatric Interview Score was assessed using 6 forms 7 days