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Completed
NCT07792265
Anesthesia and Postoperative Delirium in Parkinson DBS
Conditions: PARKINSON DISEASE (Disorder), Deep Brain Stimulation, Postoperative Delirium
Sex: All
Ages: 50 Years – 80 Years
Healthy volunteers: No
Enrollment: 400
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tian Tan Hospital Beijing
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07792265). StuddyBuddy aggregates publicly available trial information.