NCT06861764

Brief Summary

This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the the relationship between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

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

April 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 21, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

March 1, 2025

Last Update Submit

March 18, 2025

Conditions

Cohort Studies

Keywords

preoperative anxietyAgedpostoperative delirium

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium

    The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).

    within 7 days after surgery

Study Arms (2)

Preoperative anxiety

According to the GAD-7 scale, the population was defined as the Preoperative anxiety group

Non-preoperative anxiety

According to the GAD-7 scale, the population was defined as the Non-preoperative anxiety group

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (aged ≥ 65 years) who completed the anxiety assessment after the elective noncardiac, non-neurosurgical surgery were included in this study.

You may qualify if:

  • elderly patients (age ≥ 65 years)
  • non-cardiac surgery, non-neurosurgical surgery

You may not qualify if:

  • History of neurological or psychiatric disorders or use of neuropsychiatric drugs;
  • Impaired cognitive function or inability to cooperate with preoperative follow-up;
  • Sent to ICU after surgery;
  • Deletional delirium outcome;
  • Baseline missing \>5%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 6, 2025

Study Start

April 1, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

March 21, 2025

Record last verified: 2025-02

Locations

CN(1)