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

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium, Postoperative
• Intervention / Treatment: Other: NO Intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 3320

Contacts and Locations

• Study Contact: Name: Xiao Ran; Phone Number: 15926207366; Email: ranxiao1001@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Qin Zhang; Phone Number: 15717154768; Email: qzhang8@tjh.tjmu.edu.cn

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • The First Hospital of Harbin Medical University
      • Contact: Yuting Liu; Phone Number: Hongyan; Email: qin4298@sina.com
      • Contact: Yuting Ma; Phone Number: 3680; Email: qin4298@sina.com
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
      • Contact: Qin Zhang, phd; Phone Number: 15717154768; Email: qzhang8@tjh.tjmu.edu.cn
      • Contact: Xiao Ran, phd; Phone Number: 15926207366; Email: ranxiao1001@tjh.tjmu.edu.cn
      • Principal Investigator: Qin Zhang, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients entering the PACU and meeting the inclusion criteria of this study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients staying in the PACU	Other: NO Intervention; NO Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Mini-Mental State Examination, MMSE	1 Hour

Collaborators and Investigators

• Sponsor: Qin Zhang
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Qin Zhang, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: TJ-IRB202402016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No