Comparing anesthesia methods for deep brain stimulation in Parkinson's patients
Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
This study is testing whether using conscious sedation or general anesthesia during deep brain stimulation surgery helps Parkinson's patients while keeping their brain signals clear.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05550714 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different anesthesia techniques during deep brain stimulation (DBS) surgery for Parkinson's disease patients who cannot tolerate awake procedures. Participants will be randomly assigned to receive either conscious sedation with dexmedetomidine or general anesthesia with desflurane. The primary focus is to compare neuronal activity as measured by microelectrode recording (MER) between the two groups, with secondary outcomes assessing clinical results six months post-surgery. This prospective randomized controlled trial aims to identify a feasible anesthesia approach that minimizes the impact on neuronal signals during DBS.
Who should consider this trial
Good fit: Ideal candidates are Parkinson's disease patients aged 50-80 who are classified as ASA grade II-III and require bilateral STN-DBS.
Not a fit: Patients with obstructive sleep apnea, high BMI, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient comfort during DBS procedures for Parkinson's disease.
How similar studies have performed: While there have been studies on anesthesia effects during DBS, this specific comparison of dexmedetomidine and desflurane is novel and has not been extensively tested.
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 Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Ruquan Han, MD, PhD — Beijing Tiantan Hospital
- 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.