NCT05992818

Brief Summary

Postoperative delirium (POD) is a transient and usually fully reversible altered state of consciousness that develops acutely or subacutely after surgery, characterized by widespread, daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania), hypoactive (depressive) and mixed type. It has been shown to be associated with increased morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46% in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic, opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk factors associated with delirium. This condition, which has a multifactorial etiology, is often unrecognized, unpreventable, untreatable and leads to increased morbidity and mortality. Therefore, it is important to recognize delirium that develops in the postoperative period and to perform the necessary interventions. There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient under many sub-headings such as orientation, memory, attention, visual and spatial ability. The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these tests are useful for the clinician in the diagnosis of delirium. The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their feasibility and the power detecting delirium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

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

First Submitted

Initial submission to the registry

August 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 16, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

August 5, 2023

Last Update Submit

March 8, 2024

Conditions

Keywords

Elderly patientsDRS-R-98(The Delirium Rating Scale--Revised-98)3D-CAMdelirium

Outcome Measures

Primary Outcomes (1)

  • Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium.

    the specificity, sensitivity and consistency of 3D-CAM and DRS-R-98 tests used in the evaluation of postoperative delirium. Both tests include sections that assess the patient's responses to the questions asked and also the practitioner's observations

    2 days

Secondary Outcomes (3)

  • incidence of postoperative delirium

    2 days

  • length of hospital stay

    2-21 days

  • postoperative pain assessment with Numeric Rating Scale (NRS)

    2 days

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

≥ 65 years male and female orthopedic, urological, thoracic, vascular (off-pump) and general surgery operations

You may qualify if:

  • orthopedic, urological, thoracic, vascular and general surgery operations
  • Emergency and elective surgery
  • Patients with voluntary consent
  • Patients aged ≥ 65 years
  • Surgeries longer than 60 minutes

You may not qualify if:

  • \< 65 years old patients
  • Operations that take less than 60 minutes
  • Patients who do not speak Turkish
  • Patients who cannot legally give consent (eg dementia)
  • Patients without consent
  • Outpatient surgeries
  • Reoperated or reintubated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Oh ST, Park JY. Postoperative delirium. Korean J Anesthesiol. 2019 Feb;72(1):4-12. doi: 10.4097/kja.d.18.00073.1. Epub 2018 Aug 24.

  • Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.

  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5Ⓡ). 5th ed. Arlington, American Psychiatric Association Publishing. 2013, pp 596-601.

    RESULT
  • Palihnich K, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. 2014; Boston: Hospital Elder Life Program

    RESULT
  • Cinar MA,Ozmenler KN ,Ozsahin A ,Trzepacz Paula T. Dusunen Adam The Journal of Psychiatry and Neurological Sciences 2014; 3(27): 186-193 DOI: 10.5350/DAJPN2014270301

    RESULT

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

  • Zerrin SUNGUR, Prof Dr

    Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 5, 2023

First Posted

August 15, 2023

Study Start

August 16, 2023

Primary Completion

December 20, 2023

Study Completion

December 25, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations