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NCT04168268 Clinical Trial

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

Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04168268
Other study ID # PACU-DE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 28, 2017
Est. completion date December 11, 2018

Study information
Verified date November 2019
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date December 11, 2018
Est. primary completion date December 11, 2018
Accepts healthy volunteers No
Gender Male
Age group 60 Years and older
Eligibility Inclusion Criteria:

- elective radical prostatectomy

- >60 years

- fluent in German

Exclusion Criteria:

- preexisting cognitive impairment

- cerebrovascular disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Anesthesiology, University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Self-reported cognitive failures Cognitive Failures Questionnaire three months
Secondary Health-related quality of life Short Form Health Survey 36 three months
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