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

NCT ID: NCT04168268

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-28

Study Completion Date

2018-12-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Delirium Neurocognitive Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* elective radical prostatectomy
* \>60 years
* fluent in German

Exclusion Criteria

* preexisting cognitive impairment
* cerebrovascular disease
Minimum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Kainz E, Stuff K, Kahl U, Wiessner C, Yu Y, von Breunig F, Nitzschke R, Haese A, Graefen M, Fischer M. Impact of postanesthesia care unit delirium on self-reported cognitive function and perceived health status: a prospective observational cohort study. Qual Life Res. 2022 Aug;31(8):2397-2410. doi: 10.1007/s11136-022-03087-1. Epub 2022 Jan 27.

Reference Type DERIVED
PMID: 35084649 (View on PubMed)

Other Identifiers

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PACU-DE

Identifier Type: -

Identifier Source: org_study_id

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