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Recruiting NCT05550714

Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease

Trial Parameters

Condition PD - Parkinson's Disease
Sponsor Beijing Tiantan Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 188
Sex ALL
Min Age 50 Years
Max Age 80 Years
Start Date 2022-10-15
Completion 2024-03-26
Interventions
general anesthesiaConscious sedation

Brief Summary

Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a 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 the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.

Eligibility 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.

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