NCT05833308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

April 17, 2023

Last Update Submit

April 28, 2023

Conditions

Parkinson DiseaseDeep Brain StimulationPostoperative Delirium

Keywords

postoperative deliriumfibrinogen-to-albumin ratio

Outcome Measures

Primary Outcomes (4)

  • CAM score

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

    Before surgery

  • CAM score

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

    Postoperative day 1

  • CAM score

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

    Postoperative day 2

  • CAM score

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

    Postoperative day 3

Secondary Outcomes (4)

  • Mini-mental State Examination (MMSE) score

    Before surgery

  • MMSE score

    Postoperative 24 hour

  • MMSE score

    postoperative 72 hour

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

    Before surgery

Study Arms (2)

POD group

Patients who were determined to have incident postoperative delirium by a positive confusion assessment method (CAM) questionnaire after operation were defined as the POD group.

Non-POD group

Patients who did not suffer from delirium after surgery consisted of the Non-POD group.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease were scheduled to undergo elective subthalamic nucleus deep brain stimulation surgery for the first time under total intravenous anesthesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The CAM questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Parkinson DiseaseEmergence Delirium

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 27, 2023

Study Start

January 1, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations

CN(1)