Comparison of DRS-R-98 and 3D-CAM in the Assessment of Postoperative Delirium in Elderly Patients

March 8, 2024 updated by: Ozlem Turhan, Istanbul University

Comparison of DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute Diagnostic Assessment for CAM-Confusion Assessment Method-defined Delirium) in the Assessment of Postoperative Delirium in Elderly Patients

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.

Study Overview

Detailed Description

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.

After obtaining ethics committee approval, all patients who undergo orthopedic, urological, general surgery, thoracic and vascular surgery operations in the Istanbul Faculty of Medicine, above 65 years old, with an operation duration longer than 60 minutes will include in this study. Patients who are re-operated, require re-intubation or withdraw their consent will be excluded from the study. This study is planned as an observational, prospective study. Demographic information such as age, gender, height, weight, comorbidities, duration of operation and anesthesia, postoperative pain level, anesthesia and analgesia management, intensive care and hospitalization periods will be recorded from their files. On postoperative day 1, delirium development will be evaluated with DSM-5 diagnostic criteria. All patients will also be evaluated by another physician with both DRS-R-98 and 3D-CAM tests. The same tests will be repeated on postoperative day 2.

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Istanbul, Turkey
        • Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium.
Time Frame: 2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative delirium
Time Frame: 2 days
determine the incidence of postoperative delirium
2 days
length of hospital stay
Time Frame: 2-21 days
examine the relationship between delirium and hospital stay
2-21 days
postoperative pain assessment with Numeric Rating Scale (NRS)
Time Frame: 2 days
Numerical rating scales (NRSs) are the simplest and most commonly used scales.The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Zerrin SUNGUR, Prof Dr, Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

December 25, 2023

Study Registration Dates

First Submitted

August 5, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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