Optimize electrode placement using esketamine
- Trial ID
- NCT06543563
- Official Title
- Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease（ASPIRE）：A Randomized Controlled, Double-blind Study
- Goal
- Optimize electrode placement using esketamine
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Beijing Tiantan Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 102 participants
- Conditions
- PD - Parkinson's Disease, Deep Brain Stimulation, Esketamine
- Interventions
- esketamine, normal Saline
Plain-Language Summary
The goal is to find out whether using esketamine during microelectrode recording-guided subthalamic deep brain stimulation helps provide steady, safe sedation while keeping the brain signals surgeons use to place DBS leads accurate, which can improve surgery for Parkinson's motor symptoms. Esketamine is a fast-acting anesthetic that blocks NMDA receptors to give sedation and pain relief, it affects brain activity differently than levodopa which works on dopamine so it is used only during surgery rather than as a Parkinson's treatment, and the team will watch for blood pressure changes or brief hallucinatory effects during the operation. Eligible participants are adults 50 to 80 years old scheduled for bilateral STN-DBS with ASA grade II or III, and people with sleep apnea, BMI over 30, difficult airways, severe anxiety, major organ failure, or anesthesia allergies are excluded.
Locations
- Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying esketamine. The goal is to find out whether using esketamine during microelectrode recording-guided subthalamic deep brain stimulation helps provide steady, safe sedation while keeping the brain signals surgeons use to place DBS leads accurate, which can improve surgery for Parkinson's motor symptoms. Esketamine is a fast-acting anesthetic that blocks NMDA receptors to give sedation and pain relief, it affects brain activity differently than levodopa which works on dopamine so it is used only during surgery rather than as a Parkinson's treatment, and the team will watch for blood pressure changes or brief hallucinatory effects during the operation. Eligible participants are adults 50 to 80 years old scheduled for bilateral STN-DBS with ASA grade II or III, and people with sleep apnea, BMI over 30, difficult airways, severe anxiety, major organ failure, or anesthesia allergies are excluded.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 5 months.