Condition: PD - Parkinson's Disease · Dexmedetomidine · Desflurane · Sponsor: Beijing Tiantan Hospital
Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
This description comes directly from the study's public registry record.
Ruquan Han, MD, PhD · 8610-59976660 · ruquan.han@gmail.com
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| Beijing Tiantan Hospital, Capital Medical University | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05550714