Using Esketamine to Improve 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
This study is testing if adding Esketamine to a common sedative can improve brain signal quality during surgery for people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06543563 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Esketamine combined with Dexmedetomidine on microelectrode recordings during subthalamic nucleus deep brain stimulation (STN-DBS) surgery for Parkinson's disease. Patients scheduled for bilateral STN-DBS will be randomly assigned to receive either Dexmedetomidine alone or Dexmedetomidine with Esketamine under awake sedation. The primary focus is to assess the differences in neural activity using the normalized root mean square (NRMS) method, with secondary outcomes including variations in beta oscillation power. The goal is to determine if Esketamine can enhance the quality of intraoperative electrical signals without compromising patient comfort.
Who should consider this trial
Good fit: Ideal candidates are Parkinson's disease patients aged 50-80 who are scheduled for bilateral STN-DBS surgery and can provide informed consent.
Not a fit: Patients with obstructive sleep apnea, severe preoperative anxiety, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better management of motor symptoms in Parkinson's disease patients.
How similar studies have performed: While the use of Esketamine in this context is novel, similar studies have shown promising results in enhancing sedation without compromising neural monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent. Exclusion Criteria: 1. Obstructive sleep apnea; 2. BMI \> 30kg/m2; 3. Estimated difficult airway; 4. Severe preoperative anxiety; 5. Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction) 6. A history of allergy to the anaesthetics.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ruquan Han, MD,PhD — Study Principal Investigator
- Study coordinator: Ruquan Han, MD,PhD
- Email: ruquan.han@gmail.com
- Phone: 8610-59976660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.