RecruitingNot ApplicableNCT06543563

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

Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease（ASPIRE）：A Randomized Controlled, Double-blind Study

Sponsor

Beijing Tiantan Hospital

Enrollment

102 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

Esketamine Deep Brain Stimulation PD - Parkinson's Disease

Summary

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.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether the anesthetic drug esketamine can help patients with Parkinson's disease remain calm and cooperative during deep brain stimulation (DBS) surgery, which requires patients to be awake so surgeons can use tiny electrode recordings to precisely place the device. **You may be eligible if...** - You are 50–80 years old and have Parkinson's disease - You are scheduled for bilateral DBS surgery targeting a brain area called the subthalamic nucleus - You have an ASA health classification of II or III **You may NOT be eligible if...** - You have obstructive sleep apnea - Your BMI is above 30 - You have a potentially difficult airway - You have severe anxiety before the procedure - You have serious heart, kidney, or liver problems - You are allergic to anesthetic drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGesketamine

After the craniotomy, a continuous infusion of ketamine at a rate of 0.3 mg/kg/h (0.3 ml/kg/h) is administered until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. After the administration of the drug, close monitoring of the patient's blood pressure and heart rate is conducted to maintain circulatory stability.

DRUGnormal Saline

After the craniotomy, a continuous infusion of normal saline at a rate of 0.3 ml/kg/h is administered until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. After the administration of the drug, close monitoring of the patient's blood pressure and heart rate is conducted to maintain circulatory stability.