Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2024-08-01
188
Participants Needed
1
Research Sites
26 weeks
Total Duration
This research aims to evaluate the effects of two anesthesia methods during microelectrode recording (MER) guided deep brain stimulation (DBS) surgery for Parkinson's disease patients. The study compares conscious sedation using dexmedetomidine with general anesthesia using desflurane. It focuses on how these anesthesia types affect neuronal electrical signals recorded during surgery and their impact on clinical outcomes six months after the procedure. Participants are randomly assigned to one of two groups: the conscious sedation group receiving dexmedetomidine infusions to maintain sedation during surgery, and the general anesthesia group receiving a combination of drugs including desflurane for inhalation anesthesia. The anesthesia protocols include careful dosing and monitoring to maintain appropriate sedation and physiological parameters during DBS implantation and MER. Both groups undergo standard bilateral subthalamic nucleus DBS implantation with MER guidance. During the study, researchers measure the percentage of high normalized root mean square (NRMS) signals recorded during MER to assess neuronal activity. Other assessments include the length of the subthalamic nucleus, number of MER tracks, and clinical outcomes such as motor function, cognitive ability, quality of life, and adverse events up to six months post-surgery. Additional evaluations include surgical satisfaction and anesthesia-related side effects. Participants are closely monitored throughout the surgery and follow-up periods to collect comprehensive data on safety and efficacy.
CONDITIONS
Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (day of surgery)
Participants undergo bilateral STN-DBS surgery for Parkinson's disease under either general anesthesia with desflurane or conscious sedation with dexmedetomidine as assigned by randomization. Microelectrode recording (MER) is performed during surgery to guide electrode placement.
1 surgery visit (in-person)
Duration - 6 months
Participants are monitored for clinical outcomes, cognitive function, quality of life, and adverse events after surgery, including assessments up to 6 months post-operation.
Visits at 24 hours, 2 days, 3 days, and 6 months after surgery
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
R
Ruquan Han, MD, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sining Xie, Lin Shi, Wei Xiong...
https://pubmed.ncbi.nlm.nih.gov/37253497