Actively Recruiting
Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease (ASPIRE): A Randomized Controlled, Double-blind Study
Led by Beijing Tiantan Hospital · Updated on 2024-08-09
102
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the use of regional anesthesia with subthalamic nucleus deep brain stimulation (STN-DBS) to improve motor symptoms in Parkinson's disease (PD). Since many PD patients require awake sedation during this surgery, the study compares the effects of two sedation methods on brain electrical signals recorded during the procedure. This prospective, randomized, placebo-controlled, double-blind study aims to evaluate whether combining Dexmedetomidine with Esketamine influences neural activity differently than Dexmedetomidine alone in PD patients undergoing bilateral STN-DBS surgery. Participants will be randomly assigned to one of two groups: one receiving Dexmedetomidine alone, and the other receiving Dexmedetomidine combined with Esketamine during surgery. Both groups receive a loading dose and continuous infusion of Dexmedetomidine, but the second group also receives an infusion of Esketamine after craniotomy until electrode implantation is complete. Blood pressure and heart rate are closely monitored throughout the surgery to maintain stability. During the study, participants will undergo microelectrode recording (MER) of brain signals to measure neural activity using the normalized root mean square (NRMS) method, which is the primary outcome. Secondary outcomes include analysis of beta oscillation power, assessments of postoperative delirium, sleep quality, depression, anxiety, and any adverse events. Patient satisfaction with the surgical experience and DBS therapy will also be evaluated. The study will monitor participants from surgery through 30 days post-operation, with follow-up assessments to track recovery and well-being.
CONDITIONS
Brief 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
- 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, kidney, or liver dysfunction
- History of allergy to anesthetics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Surgery day
Participants receive sedation with either Dexmedetomidine alone or Dexmedetomidine combined with Esketamine during bilateral STN-DBS surgery, including craniotomy, drug infusion, and microelectrode recording.
1 surgery day visit (in-person) including drug administration and monitoring
Duration - Up to 30 days after surgery
Participants are assessed for postoperative sleep quality, anxiety, depression, delirium, adverse events, and satisfaction after surgery.
Approximately 6 visits: daily assessments for the first 3 days, 1 visit at 24 hours after surgery, and visits at 30 days and 1 month post-surgery
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
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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