Postoperative Delirium in the Post-anesthesia Care Unit

NCT06318364 — Unknown, 3320 participants, Qin Zhang

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

Registry	NCT06318364
Status	Unknown
Study type	Observational
Enrollment	3320 (Estimated)
Sponsor	Qin Zhang (Other); collaborators: National Natural Science Foundation of China
Conditions	Delirium, Postoperative
Interventions	NO Intervention (Other)
Dates	start 2024-01-20, primary completion 2024-12-30 (estimated), completion 2024-12-30 (estimated), first posted 2024-03-19, last updated 2024-03-19
Locations	2 sites in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Patients staying in the PACU		Other: NO Intervention	Patients staying in the PACU

NO Intervention (Other): NO Intervention

+Outcome measures

Primary outcomes

Postoperative delirium [1 Hour]: Mini-Mental State Examination, MMSE

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
The First Hospital of Harbin Medical University	Harbin, Heilongjiang	China	Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan, Hubei	China	Recruiting

+Investigators

Qin Zhang, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology