Biomarkers and Postoperative Delirium in Elderly Patients

Recruiting

• Conditions: Postoperative Delirium
• Interventions: Behavioral: postoperative delirium

• Registration Number: NCT05454228
• Lead Sponsor: Henan Provincial People's Hospital

Brief Summary

This study intends to verify and explore the correlation of neuroinflammation biomarkers in cerebrospinal fluid and plasma of elderly patients undergoing hip replacement with postoperative delirium, so as to achieve a new method to predict whether patients will develop postoperative delirium and improve the prognosis of elderly patients with postoperative delirium. Reduce the probability of postoperative complications, improve the long-term survival rate of patients after surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-07
• Study Start: 2022-07-01
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. age≥65
2. Patients undergoing hip replacement under spinal anesthesia
3. ASA grade I~III;
4. Voluntarily participate in this study, and informed consent was signed by the patients themselves and their families

Exclusion Criteria

1. Patients with multiple fractures and trauma
2. Patients with preoperative cognitive dysfunction determined by MMSE scale;
3. Severe impairment of hearing, visual and language system functions;
4. Not suitable for or unwilling to undergo subarachnoid anesthesia
5. Patients who refuse to participate or cannot cooperate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delirium	postoperative delirium	-
Non-delirium	postoperative delirium	-

Primary Outcome Measures

Name	Time	Method
neuroinflammatory biomarkers	preoperative、24 hours after surgery、48 hours after surgery	Whether there are changes in neuroinflammatory biomarkers(Ykl40(pg/mL), procalcitonin(ng/mL), IL-17A,IL-23,INF-γ(IU), Tau(pg/mL), amyloid beta(pg/mL),etc) in cerebrospinal fluid and plasma between delirium patients and non-delirium patients before and after operation.

Trial Locations

Locations (1)

Henan People's Hospital; 🇨🇳 Zhengzhou, Henan, China