NCT04656379

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

November 30, 2020

Last Update Submit

February 9, 2022

Conditions

Delirium in Old Age

Keywords

postoperative deliriumelderlyspine surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    Incidence of delirium after spine surgery

    through study completion, postoperative period up to 2 years after surgery

Interventions

spine surgeryPROCEDURE

Risk factors for postoperative delirium in elderly patients underwent spine surgery will be evaluated.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged ≥65 and underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital

You may qualify if:

  • Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital

You may not qualify if:

  • Patients who had no information on postoperative care and managements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Youn Joung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

September 1, 2019

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

KR(1)