Choice of Anaesthesia in Microelectrode Recording-Guided Deep-Brain Stimulation for Parkinson's Disease(CHAMPION)

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Subthalamic nucleus(STN)-deep brain stimulation(DBS) under general anesthesia has been applied to PD patients who can not tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording(MER) to some degrees.

This study is a prospective randomized controlled, non-inferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN- DBS are randomly divided into conscious sedation group (dexmedetomidine) and general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high-NRMS recorded by MER signal (with the average NRMS recorded by MER after entering STN greater than 2.0). The secondary outcomes are the NRMS, lengths of STN, the numbers of MER tracks, the differences of clinical outcomes 6 months after operation.etc.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Anesthetics

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.