- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04656379
The Incidence and Risk Factors of Postoperative Delirium
February 9, 2022 updated by: Youn Joung Cho, MD, PhD, Seoul National University Hospital
The Incidence and Risk Factors of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery.
Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance.
However, there have been few reports concerning intraoperative modifiable risk factors, such as postoperative pain, for postoperative delirium.
Study Overview
Detailed Description
In this observational study, we will review the electronic medical records of elderly patients underwent spine surgery and assess the incidence and risk factors for postoperative delirium.
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients aged ≥65 and underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital
Description
Inclusion Criteria:
- Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital
Exclusion Criteria:
- Patients who had no information on postoperative care and managements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of delirium
Time Frame: through study completion, postoperative period up to 2 years after surgery
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Incidence of delirium after spine surgery
|
through study completion, postoperative period up to 2 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
February 10, 2022
Study Completion (Actual)
February 10, 2022
Study Registration Dates
First Submitted
November 30, 2020
First Submitted That Met QC Criteria
November 30, 2020
First Posted (Actual)
December 7, 2020
Study Record Updates
Last Update Posted (Actual)
February 11, 2022
Last Update Submitted That Met QC Criteria
February 9, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- delirium_risk factors
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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