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
Plain-Language Summary
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.