Anesthesia and Postoperative Delirium in Parkinson DBS

NCT07792265 | Completed DMC

• 1 other identifier: HX-B-2022035
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder, with a rising incidence due to global aging. Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) is a core therapeutic modality for motor symptoms in patients with moderate-to-advanced PD. However, Postoperative Delirium (POD) is a common and significant complication following DBS surgery, affecting up to 42.6% of patients. POD is associated with prolonged hospitalization, increased medical costs, and poorer neurological prognosis. Current evidence regarding the incidence of POD after STN-DBS and the impact of different anesthesia management strategies remains limited, with a lack of large-scale prospective studies. This study aims to prospectively investigate the incidence, risk factors, and anesthesia-related neuroprotective mechanisms of POD in PD patients undergoing STN-DBS. Specifically, the study seeks to: Determine the incidence of POD within 3 days postoperatively. Analyze the correlation between anesthesia management (including anesthetic agents, depth, and hemodynamics) and the occurrence of POD. Explore the interaction between POD and postoperative non-motor symptoms such as pain, sleep disturbances, and long-term cognitive function. Construct a multidimensional prediction model for POD based on preoperative and intra-operative data.

Conditions

PARKINSON DISEASE (Disorder); Deep Brain Stimulation; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• POD incidence

  Postoperative delirium will be assessed using the 3-Minute Diagnostic Interview for CAM (3D-CAM). Delirium will be recorded as a dichotomous outcome (present/absent) according to the diagnostic criteria of the 3D-CAM.

  Assessed daily for 3 consecutive days postoperatively (within the first 72 hours after surgery).

Secondary Outcomes (7)

• Severity of Postoperative Delirium

  Assessed daily during the first 3 postoperative days (within 72 hours after surgery) in participants diagnosed with postoperative delirium.

• Anxiety symptoms - HAMA total score

  Assessed before surgery and 30 days after surgery.

• Depressive symptoms - HAMD total score

  Assessed before surgery and 30 days after surgery.

• Health-related quality of life - PDQ-39 total score

  Assessed before surgery and 30 days after surgery.

• Anesthesia-related adverse events - Nausea

  Assessed within 24 hours postoperatively.

Other Outcomes (2)

• Patient satisfaction with surgical experience

  Assessed at 24 hours postoperatively.

• Patient satisfaction with DBS treatment

  Assessed at 30 days postoperatively.

Study Arms (2)

PD Patients with POD

Intervention: None Description: Patients diagnosed with Postoperative Delirium (POD) within 3 days after STN-DBS surgery. Anesthesia management was performed according to standard clinical protocol; no specific experimental drug or procedure was administered beyond routine care.

PD Patients without POD

Intervention: None Description: Patients who did NOT develop Postoperative Delirium (POD) after STN-DBS surgery. Anesthesia management was performed according to standard clinical protocol; no specific experimental drug or procedure was administered beyond routine care.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll patients diagnosed with Parkinson's Disease (PD) who are scheduled to undergo bilateral Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) surgery at Beijing Tiantan Hospital. The target population consists of adult patients aged 50 to 80 years with idiopathic Parkinson's Disease who are indicated for DBS surgery due to motor complications despite optimal medical therapy. Participants will be recruited consecutively from the outpatient department of Neurology and Functional Neurosurgery at Beijing Tiantan Hospital. A total sample size of 400 patients is planned to ensure adequate statistical power for the analysis of postoperative delirium incidence and risk factors.

You may qualify if:

• Aged 50-80 years old
• American Society of Anesthesiologists (ASA) physical status classification II-III
• Scheduled for bilateral subthalamic nucleus deep brain stimulation (STN-DBS) for Parkinson's disease
• Signed informed consent prior to enrollment

You may not qualify if:

• Obstructive sleep apnea
• Body mass index (BMI) \>30 kg/m²
• Predicted difficult airway
• Severe preoperative anxiety
• Severe dysfunction of vital organs (e.g., heart failure, renal or hepatic dysfunction)
• History of allergy to anesthetic agents

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Parkinson Disease; Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: August 28, 2026
• Study Start: May 1, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)