Improve electrode placement during surgery
- Trial ID
- NCT05550714
- Official Title
- Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
- Goal
- Improve electrode placement during surgery
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Beijing Tiantan Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 188 participants
- Conditions
- PD - Parkinson's Disease, Dexmedetomidine, Desflurane, Deep Brain Stimulation
- Interventions
- general anesthesia, Conscious sedation
Summary For Families
It aims to find out whether using general anesthesia with desflurane is no worse than conscious sedation with dexmedetomidine during the microelectrode recording step of bilateral subthalamic nucleus DBS, looking at the quality of brain signals, accuracy of electrode placement, and patient safety and comfort. One approach gives full inhaled anesthesia with desflurane, which puts patients fully asleep but can dampen the neural signals surgeons use for mapping, the other uses dexmedetomidine for lighter, cooperative sedation that preserves breathing and allows surgeons to test responses during surgery. The trial is enrolling people aged 50 to 80 having bilateral STN-DBS with ASA physical status II or III who can give consent. People with obstructive sleep apnea, BMI over 30, predicted difficult airways, severe preoperative anxiety, major organ failure, or allergies to the anesthetics are not eligible.
Locations
- Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying general anesthesia. It aims to find out whether using general anesthesia with desflurane is no worse than conscious sedation with dexmedetomidine during the microelectrode recording step of bilateral subthalamic nucleus DBS, looking at the quality of brain signals, accuracy of electrode placement, and patient safety and comfort. One approach gives full inhaled anesthesia with desflurane, which puts patients fully asleep but can dampen the neural signals surgeons use for mapping, the other uses dexmedetomidine for lighter, cooperative sedation that preserves breathing and allows surgeons to test responses during surgery. The trial is enrolling people aged 50 to 80 having bilateral STN-DBS with ASA physical status II or III who can give consent. People with obstructive sleep apnea, BMI over 30, predicted difficult airways, severe preoperative anxiety, major organ failure, or allergies to the anesthetics are not eligible.
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.