Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

NCT02210312 | Completed

• 1 other identifier: PV4646
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months. In some cases, changes are permanent.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium; Depressive Symptoms

Outcome Measures

Primary Outcomes (3)

• Frequency of occurrence of early POCD

  POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)

  7 days

• Frequency of occurrence of intermediate POCD

  POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)

  3 months

• Frequency of occurrence of late POCD

  POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)

  1 year

Secondary Outcomes (5)

• Frequency of occurrence of postoperative delirium

  7th postoperative day

• Rate of organ complications (cardiac, respiratory, renal)

  day of operation until 7th postoperative day

• Hospital length of stay

  day of admission until day of discharge, up to 24 weeks

• Mortality

  1 year

• Health related quality of life

  7 days, 3 months, 1 year after operation

Other Outcomes (8)

• Dementia

  Change from baseline sum score on the Mini-Mental State Examination (2nd ed.) [Time Frame: Before operation to 7 days, 3 months and 1 year after operation].

• Preoperative depressive symptoms and anxiety

  Baseline

• Past or present diagnosed depression

  Baseline

Study Arms (1)

elective non-cardiac surgery and non-neurosurgical procedures

300 Patients aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia with a duration of operation of 120 minutes or longer. 80 age-, gender- and education-matched healthy controls.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female and male patients, aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia. To correct for practice effects and conduct additional comparisons, 80 healthy controls will be enrolled and assessed at the same time points (neuropsychological tests and questionnaires).

You may qualify if:

• Age \> 60 years
• Written informed patient's consent
• Elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia
• Minimum of duration of operation 120 minutes
• Baseline testing 3-14 days preoperatively
• matched for age, gender and education
• no surgery over the study period

You may not qualify if:

• German not mother tongue
• Illiteracy
• Mental disability
• Vision impairment not correctable
• Hearing impairment not correctable
• Illegal substance abuse (current or past history)
• Alcohol abuse (current or past history)
• Chronic benzodiazepine use
• Psychosis (current or past history)
• Parkinson Disease
• Dementia
• Multiple sclerosis
• Epilepsy (current or past history)
• Cerebral tumor (current or past history)
• Apoplexy or intracranial bleeding (current or past history)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium; Depression

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Julia Wiede, MD

  Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: August 6, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

DE (1)