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Postoperative Delirium in the Post-anesthesia Care Unit

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06318364
Enrollment
3320
Registered
2024-03-19
Start date
2024-01-20
Completion date
2024-12-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Postoperative

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.

Interventions

OTHERNO Intervention

NO Intervention

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Qin Zhang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative delirium1 HourMini-Mental State Examination, MMSE

Countries

China

Contacts

Primary ContactXiao Ran
ranxiao1001@tjh.tjmu.edu.cn15926207366
Backup ContactQin Zhang
qzhang8@tjh.tjmu.edu.cn15717154768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026