- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05992818
Comparison of DRS-R-98 and 3D-CAM in the Assessment of Postoperative Delirium in Elderly Patients
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
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Tuğçe DİNÇ DOĞAN, MD
- Phone Number: 00905379412059
- Email: tugce_dinc@hotmail.com
Study Contact Backup
- Name: Ozlem TURHAN, MD
- Phone Number: 00905055381923
- Email: ozlemturhan6@gmail.com
Study Locations
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Istanbul, Turkey
- Istanbul Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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
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2 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of postoperative delirium
Time Frame: 2 days
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determine the incidence of postoperative delirium
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2 days
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length of hospital stay
Time Frame: 2-21 days
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examine the relationship between delirium and hospital stay
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2-21 days
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postoperative pain assessment with Numeric Rating Scale (NRS)
Time Frame: 2 days
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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."
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2 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zerrin SUNGUR, Prof Dr, Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation
Publications and helpful links
General Publications
- 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.
- Palihnich K, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. 2014; Boston: Hospital Elder Life Program
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/2132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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