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NCT Number: NCT07792265

Anesthesia and Postoperative Delirium in Parkinson DBS

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.

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Key information

About this study

Parkinson's disease (PD) is a chronic progressive neurodegenerative disorder characterized by both motor symptoms (bradykinesia, resting tremor, rigidity, postural instability) and non-motor symptoms, among which cognitive impairment is a prevalent and debilitating complication. Subthalamic nucleus deep brain stimulation (STN-DBS) has been a standard therapy for advanced PD for nearly three decades, with well-established long-term benefits for motor symptom control. However, perioperative cognitive dysfunction remains a major concern: the incidence of postoperative cognitive dysfunction (POCD) in elderly surgical patients ranges from 10% to 54%, and PD patients are inherently at higher baseline risk of cognitive decline due to underlying neurodegeneration.

Anesthetic management is a critical modifiable factor in STN-DBS procedures. Clinically, regional anesthesia with awake sedation is preferred for most PD patients to allow intraoperative neurophysiological monitoring and behavioral assessment; however, a subset of patients cannot tolerate awake surgery due to severe rigidity, tremor, or anxiety, requiring adjusted anesthetic regimens. Notably, anesthetic agents can interfere with microelectrode recording (MER) signals to varying degrees, potentially affecting electrode targeting accuracy, while different anesthetic strategies may also differentially impact postoperative neurocognitive outcomes via mechanisms such as neuroinflammation, oxidative stress, or modulation of beta oscillatory activity in the basal ganglia. To date, no prospective study has systematically evaluated the long-term cognitive trajectory of PD patients after STN-DBS or compared the neurocognitive safety profiles of different anesthesia management protocols in this population.

This prospective cohort study will enroll PD patients scheduled for bilateral STN-DBS and assign them to cohorts based on their clinically determined anesthesia management strategy (regional anesthesia with awake sedation vs. modified sedation/anesthesia regimens for patients intolerant to awake surgery). Beyond the primary outcome of POCD incidence, the study will collect intraoperative MER data (root mean square values of MER signals, beta band power via discrete Fourier transform of sampling windows) to explore potential associations between anesthetic exposure, electrophysiological signal quality, and postoperative cognitive outcomes. All enrolled patients will undergo serial cognitive and non-motor symptom assessments at predefined perioperative timepoints to establish cognitive trajectories, identify anesthetic and non-anesthetic risk factors for POCD via multivariable regression, and provide evidence for personalized anesthesia management in PD patients undergoing DBS.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. POD incidence

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

    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.

Secondary outcomes

  1. Severity of Postoperative Delirium

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

    Delirium severity will be assessed using the Confusion Assessment Method-Severity (CAM-S). The full CAM-S score ranges from 0 to 19 with higher scores indicating greater delirium severity. CAM-S will be assessed in participants who meet the diagnostic criteria for postoperative delirium.

  2. Anxiety symptoms - HAMA total score

    Time frame: Assessed before surgery and 30 days after surgery.

    Hamilton Anxiety Rating Scale (HAMA) total score, ranging from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.

  3. Depressive symptoms - HAMD total score

    Time frame: Assessed before surgery and 30 days after surgery.

    Hamilton Depression Rating Scale (HAMD) total score, ranging from 0 to 52, with higher scores indicating greater severity of depressive symptoms.

  4. Health-related quality of life - PDQ-39 total score

    Time frame: Assessed before surgery and 30 days after surgery.

    Parkinson's Disease Questionnaire-39 (PDQ-39) total score, ranging from 0 to 156, with higher scores indicating worse health-related quality of life.

  5. Anesthesia-related adverse events - Nausea

    Time frame: Assessed within 24 hours postoperatively.

    Incidence of nausea, recorded as a dichotomous outcome (present/absent).

  6. Anesthesia-related adverse events - Vomiting

    Time frame: Assessed within 24 hours postoperatively.

    Incidence of vomiting, recorded as a dichotomous outcome (present/absent).

  7. Anesthesia-related adverse events - Intraoperative awareness

    Time frame: Assessed within 24 hours postoperatively.

    Incidence of intraoperative awareness, recorded as a dichotomous outcome (present/absent).

Other outcomes

  1. Patient satisfaction with surgical experience

    Time frame: Assessed at 24 hours postoperatively.

    Patient satisfaction with the surgical experience, assessed using a 7-point Likert scale ranging from 1 to 7, with higher scores indicating greater satisfaction.

  2. Patient satisfaction with DBS treatment

    Time frame: Assessed at 30 days postoperatively.

    Patient satisfaction with DBS treatment, assessed using a 7-point Likert scale ranging from 1 to 7, with higher scores indicating greater satisfaction.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

A Prospective Cohort Study on Anesthesia-Related Neuroprotective Mechanisms and Prediction Models for Postoperative Delirium After Deep Brain Stimulation in Parkinson's Disease

Acronym: POD-DBS-PD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

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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