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OpenTrials
Completed

NCT Number: NCT04168268

Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium

To assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

Completed

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

Neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. Postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. Post-anesthesia care unit (PACU) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery.

It is unclear, whether PACU delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. The aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without PACU delirium three months after radical prostatectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective radical prostatectomy
  • >60 years
  • fluent in German

Exclusion criteria

  • preexisting cognitive impairment
  • cerebrovascular disease

Treatment and study plan

Primary outcomes

  1. Self-reported cognitive failures

    Time frame: three months

    Cognitive Failures Questionnaire

Secondary outcomes

  1. Health-related quality of life

    Time frame: three months

    Short Form Health Survey 36

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Influence of Post-anesthesia Care Unit Delirium After Radical Prostatectomy on Self-reported Cognitive Function and Health-related Quality of Life

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2019
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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