PARKINSON DISEASE (Disorder)POD-DBS-PDNCT07792265
Anesthesia and Postoperative Delirium in Parkinson DBS
An observational study of PARKINSON DISEASE (Disorder) and Deep Brain Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Deep Brain Stimulation, Postoperative Delirium
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Jan 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study on Anesthesia-Related Neuroprotective Mechanisms and Prediction Models for Postoperative Delirium After Deep Brain Stimulation in Parkinson's Disease
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.
Read more
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.
Read the detailed description
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.
- Medical subject headings
- Parkinson Disease, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed daily for 3 consecutive days postoperatively (within the first 72 hours after surgery).
Secondary outcomes (7)
Severity of 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.
Measured: Assessed daily during the first 3 postoperative days (within 72 hours after surgery) in participants diagnosed with postoperative delirium.
Anxiety symptoms - HAMA total score
Hamilton Anxiety Rating Scale (HAMA) total score, ranging from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.
Measured: Assessed before surgery and 30 days after surgery.
Depressive symptoms - HAMD total score
Hamilton Depression Rating Scale (HAMD) total score, ranging from 0 to 52, with higher scores indicating greater severity of depressive symptoms.
Measured: Assessed before surgery and 30 days after surgery.
Health-related quality of life - PDQ-39 total score
Parkinson's Disease Questionnaire-39 (PDQ-39) total score, ranging from 0 to 156, with higher scores indicating worse health-related quality of life.
Measured: Assessed before surgery and 30 days after surgery.
Anesthesia-related adverse events - Nausea
Incidence of nausea, recorded as a dichotomous outcome (present/absent).
Measured: Assessed within 24 hours postoperatively.
Anesthesia-related adverse events - Vomiting
Incidence of vomiting, recorded as a dichotomous outcome (present/absent).
Measured: Assessed within 24 hours postoperatively.
Anesthesia-related adverse events - Intraoperative awareness
Incidence of intraoperative awareness, recorded as a dichotomous outcome (present/absent).
Measured: Assessed within 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 May 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792265
- Sponsor's protocol ID
- HX-B-2022035
- Acronym
- POD-DBS-PD
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes