Postoperative Delirium in the Post-anesthesia Care Unit

NCT ID: NCT06318364

Last Updated: 2024-03-19

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

RECRUITING

Total Enrollment

3320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-20

Study Completion Date

2024-12-30

Brief Summary

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This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD.

Detailed Description

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Study design type: Multi-center, observational, case-control study based on propensity score matching. The leading unit is Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and the participating unit is The First Hospital of Harbin Medical University.

Record general clinical information, surgical-anesthesia-related information, recovery indicators, pain status, adverse events in PACU, and occurrences of postoperative delirium of all study subjects meeting the inclusion criteria of this study. Based on the occurrence of postoperative delirium, the subjects will be divided into delirium group and non-delirium group for univariate analysis. Univariate factors with statistical significance will be included in a multiple logistic regression analysis to further identify risk factors for postoperative delirium. Some selected factors can undergo ROC curve analysis to calculate the optimal cutoff value. Due to the limited number of subjects experiencing postoperative delirium, propensity score matching will be used to improve the statistical efficiency for analysis of risk factors for postoperative delirium. Furthermore, for patients with postoperative delirium, a small amount of blood samples will be collected by the researchers for analysis of inflammatory factors and other components.

Conditions

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Delirium, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients staying in the PACU

Patients staying in the PACU

NO Intervention

Intervention Type OTHER

NO Intervention

Interventions

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NO Intervention

NO Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients voluntarily participating in this study
2. Age ≥18 years old
3. ASA classification I-IV
4. Complete clinical data

Exclusion Criteria

1. ASA classification V and above
2. History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23
3. Patients with communication barriers
4. Patients with missing clinical data
5. Patients with severe complications during PACU observation requiring reintubation, reoperation, or transfer to the intensive care unit for further treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Qin Zhang

OTHER

Sponsor Role lead

Responsible Party

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Qin Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qin Zhang

Role: PRINCIPAL_INVESTIGATOR

Tongji Medical College, Huazhong University of Science and Technology

Locations

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The First Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao Ran

Role: CONTACT

15926207366

Qin Zhang

Role: CONTACT

15717154768

Facility Contacts

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Yuting Liu

Role: primary

Yuting Ma

Role: backup

Xiao Ran, phd

Role: primary

15926207366

Qin Zhang, phd

Role: backup

15717154768

Other Identifiers

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TJ-IRB202402016

Identifier Type: -

Identifier Source: org_study_id

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