NCT02227225

Brief Summary

Postoperative delirium has been found to be associated with increased risk of future neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has been found to be associated with an increased risk of postoperative complication including delirium in the elderly.The purpose of this study is determine the factors affecting the incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the Singapore population.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

August 26, 2014

Last Update Submit

January 13, 2015

Conditions

Postoperative Delirium

Keywords

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

  • postoperative delirium

    Confusion assessment method (CAM) will be used to asses delirium

    upto 3 postoperative days

Study Arms (1)

Postoperative Delirium

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative inpatients

You may qualify if:

  • Elderly (\> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for \>60 minutes
  • Patient willing and able to complete the requirements of this study.

You may not qualify if:

  • disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression)
  • patients suffering from delirium at selection;
  • patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shariq A Khan, FRCA

CONTACT

Shariq.ali.khan@sgh.com.sg

Study Design

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

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

SG(1)