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Completed

NCT Number: NCT05833308

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Confusion Deep Brain Stimulation Delirium Emergence Delirium Mental Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Signs and Symptoms Synucleinopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CAM score

    Time frame: Before surgery

    Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

  2. CAM score

    Time frame: Postoperative day 1

    Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

  3. CAM score

    Time frame: Postoperative day 2

    Positive CAM score means that patient developed delirium after surgery. While negative CAM score means that patient did not suffer from delirium after surgery.

  4. CAM score

    Time frame: 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 outcomes

  1. Mini-mental State Examination (MMSE) score

    Time frame: Before surgery

    MMSE score ranges from 0 to 30 and higher score means better cognitive function.

  2. MMSE score

    Time frame: Postoperative 24 hour

    MMSE score ranges from 0 to 30 and higher score means better cognitive function.

  3. MMSE score

    Time frame: postoperative 72 hour

    MMSE score ranges from 0 to 30 and higher score means better cognitive function.

  4. The level of fibrinogen-to-albumin ratio (FAR) in peripheral blood.

    Time frame: Before surgery

    The FAR was calculated as fibrinogen / albumin.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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