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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Ruquan Han, MD,PhD
ruquan.han@gmail.com
8610-59976660
Time Frame
Start Date: 2024-08-09
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 102
Treatments
Placebo_comparator: DEX
A loading dose of DEX 0.3 µg/kg was infused intravenously at a constant speed within 10 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.3µg/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. After the craniotomy, normal saline is infused at a rate of 3 ml/kg/h until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. Blood pressure and heart rate of the patient are closely monitored after drug administration to maintain circulatory stability.
Experimental: DEX-KET
A loading dose of DEX 0.3 µg/kg was infused intravenously at a constant speed within 10 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.3µg/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. After the craniotomy, esketamine (0.1mg/ml) is infused at a rate of 3ml/kg/h until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. Blood pressure and heart rate of the patient are closely monitored after drug administration to maintain circulatory stability.
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov