Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

NCT ID: NCT02210312

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-10-31

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.

Detailed Description

The aetiology of POCD is multifactorial. One described risk factor is preoperative existing depressive symptoms in patients undergoing cardiac surgery.

A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive function will be tested and compared to tests done before surgery. Postoperatively - from the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.

Next to preoperative depressive symptoms we will also evaluate a diagnosed depression, anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical insufficiency, type of anaesthesia, intraoperative blood loss, organ complications, postoperative delirium, baseline cognitive functioning and the number of operations/anaesthetics in the study period after the initial operation as further potential predictors of POCD.

In addition, laboratory values and certain medications will be documented. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate and cortisone therapy.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium; Depressive Symptoms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Severe traumatic brain injury (current or past history)
• Severe liver disease (Child Pugh B, C, liver insufficiency)
• Severe kidney disease with dialysis
• Mini Mental Status Examination < 24 points

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Wiede, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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, , Germany

Countries

Germany

Other Identifiers

PV4646

Identifier Type: -

Identifier Source: org_study_id