Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease

Completed

• Conditions: Postoperative Delirium; Parkinson Disease; Deep Brain Stimulation

• Registration Number: NCT05833308
• Lead Sponsor: Changhai Hospital

Brief Summary

Postoperative delirium (POD) remains one of the most common neuropsychiatric complications after deep brain stimulation (DBS) surgery. The fibrinogen-to-albumin ratio (FAR) has been shown to significantly correlate with prognosis of many diseases associated with inflammation, but the relationship between FAR and POD is unclear. The investigators aimed to investigate the association between POD and FAR in Parkinson's disease (PD) patients receiving DBS surgery. For this aim, the present study was conducted to provide a new method for the early recognition and perioperative management of delirium after DBS surgery in PD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-27
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Over 55 years old
• American Society of Anesthesiologists (ASA) physical status I-III
• Bilateral subthalamic nucleus deep brain stimulation surgery

Exclusion Criteria

• Preoperative delirium
• Missing preoperative laboratory parameters on fibrinogen or albumin
• Persistent infectious diseases
• Coagulopathy and autoimmune-illness or malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAM score	Postoperative day 3	Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

Secondary Outcome Measures

Name	Time	Method
Mini-mental State Examination (MMSE) score	Before surgery	MMSE score ranges from 0 to 30 and higher score means better cognitive function.
The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.	Before surgery	The FAR was calculated as fibrinogen / albumin.
MMSE score	postoperative 72 hour	MMSE score ranges from 0 to 30 and higher score means better cognitive function.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China