Actively Recruiting
Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease
Led by Beijing Tiantan Hospital · Updated on 2024-08-09
102
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Under regional anesthesia, subthalamic nucleus deep brain stimulation (STN-DBS) has proven to be an effective therapeutic approach for improving motor symptoms in Parkinson's disease. However, a significant portion of Parkinson's disease (PD) patients is unable to cooperate with the surgery, necessitating the use of awake sedation. Nevertheless, the administration of anesthetic drugs often impacts the electrical signals recorded by microelectrodes to varying degrees. This study is designed as a prospective, randomized, placebo-controlled, double-blind, two-arm investigation. PD patients scheduled for bilateral STN-DBS surgery will be randomly assigned to either the Dexmedetomidine group or the Dexmedetomidine combined with Esketamine group. The differences in neural activity between the two groups will be assessed using the normalized root mean square (NRMS) method. The primary outcome measure is NRMS, while secondary outcome measures include differences in beta oscillation power spectrum analysis, postoperative delirium incidence, postoperative changes in sleep disturbances, postoperative depression, anxiety status, and occurrence of adverse events.
CONDITIONS
Official Title
Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years, ASA grade II-III
- Patients scheduled for bilateral STN-DBS surgery for Parkinson's disease
- Signed informed consent
You will not qualify if you...
- Obstructive sleep apnea
- Body mass index (BMI) greater than 30 kg/m2
- Estimated difficult airway
- Severe preoperative anxiety
- Serious dysfunction of important organs such as heart failure, renal or liver dysfunction
- History of allergy to anesthetic drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
R
Ruquan Han, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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