NCT04215263

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

December 30, 2019

Last Update Submit

February 19, 2020

Conditions

Undergoing General Anaesthesia

Keywords

postoperative cognitive dysfunctiongeriatricsgeneral anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Mini International Neuropsychiatric Interview

    Score was assessed using 6 forms

    7 days

Study Arms (1)

Geriatric patient underwent general anesthesia procedure

geriatric patients (≥60 years) ware assessed for cognitive impairment after general anesthesia for non-neurologic noncardiac surgery.

Other: Questionaire

Interventions

QuestionaireOTHER

Patient was assessed using mini international neuropsychiatric interview

Geriatric patient underwent general anesthesia procedure

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesia University

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • 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.

    PMID: 13243706RESULT

  • 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.

    PMID: 24303859RESULT

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

    PMID: 24622758RESULT

  • 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.

    PMID: 14616316RESULT

  • 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.

    PMID: 22321085RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Aries Perdana, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

May 1, 2019

Primary Completion

July 5, 2019

Study Completion

July 5, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)