NCT02131181

Brief Summary

The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

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

First Submitted

Initial submission to the registry

November 23, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

November 23, 2013

Last Update Submit

February 2, 2015

Conditions

Keywords

Delirium, postoperative delirium, elderly

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative delirium

    participants will be followed for the duration of hospital stay, an expected average of 1 week.

    participants will be followed for the duration of hospital stay, an expected average of 1 week.

Secondary Outcomes (2)

  • Factor related to postoperative delirium

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Long-term outcomes (cognitive impairment)

    3 and 6 months after operation

Study Arms (1)

Delirium

Patients with delirium and patients without delirium

Eligibility Criteria

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

Patients undergoing scheduled non-cardiac operation

You may qualify if:

  • Age \>/ 60 years
  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Undergoing scheduled surgery
  • Giving an informed consent

You may not qualify if:

  • Impaired visual and auditory disturbance
  • Cannot communicate with Thai language
  • Undergoing neurosurgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Maung, Chiang Mai, 50200, Thailand

Location

Related Publications (1)

  • Banjongrewadee M, Wongpakaran N, Wongpakaran T, Pipanmekaporn T, Punjasawadwong Y, Mueankwan S. The role of perceived stress and cognitive function on the relationship between neuroticism and depression among the elderly: a structural equation model approach. BMC Psychiatry. 2020 Jan 20;20(1):25. doi: 10.1186/s12888-020-2440-9.

Related Links

MeSH Terms

Conditions

Emergence DeliriumDelirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Tanyong Pipanmekaporn, MD

    Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 23, 2013

First Posted

May 6, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations