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Clinical Trials/NCT06318364
NCT06318364
Recruiting
Not Applicable

Analysis of the Incidence and Influencing Factors of Postoperative Delirium in the Post-anesthesia Care Unit: A Multicenter, Observational, Matched Case-control Study

Qin Zhang2 sites in 1 country3,320 target enrollmentJanuary 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium, Postoperative
Sponsor
Qin Zhang
Enrollment
3320
Locations
2
Primary Endpoint
Postoperative delirium
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2024
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Qin Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Qin Zhang

Professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients voluntarily participating in this study
  • Age ≥18 years old
  • ASA classification I-IV
  • Complete clinical data

Exclusion Criteria

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

Outcomes

Primary Outcomes

Postoperative delirium

Time Frame: 1 Hour

Mini-Mental State Examination, MMSE

Study Sites (2)

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