Effect of the Anticholinergic Drug Burden on Postoperativ... | NCT06931353

Studies
Effect of the Anticholinergic Drug Burden on Postoperative Delirium in Elderly Chinese Patients: A Nested Case-Control Study

NCT06931353

Sponsor

Hao Li

Status

Completed

Last Update Posted

Apr 17, 2025Actual

Enrollment

10,536Actual

Phase

Not provided

Conditions

Delirium - Postoperative

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Apr 9, 2025

First Submission Date that Met QC Criteria

Apr 9, 2025

First Posted Date

Apr 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2025

Last Update Posted Date

Apr 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the association between preoperative anticholinergic drugs burden and postoperative delirium in elderly Chinese patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,536Actual

Measure	Description	Time Frame
postoperative delirium		7 days after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients over 65 years; Undergoing general anesthesia; Inpatients who had surgery between Aprill 1, 2020 and Aprill 1, 2022.

Exclusion Criteria:

ASA grade V; preoperative Mini-Mental State Examination (MMSE) score <24;history of neurological disorders (such as cerebrovascular disease or dementia); emergency surgeries; operative duration ≤30 minutes, and cases with >5% missing data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

90 Years

Standard Ages

Older Adult

Study Population

patients over 65 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Medical Center of Chinese PLA General Hospital		Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided