Comparing Esketamine and Dexmedetomidine During Awake Sedation for Subthalamic Nucleus Deep Brain Stimulation in Parkinsons Disease Patients A Randomized, Double-Blind Clinical Trial

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 Parkinsons 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.

Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease