drugset / Trial / NCT05550714

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

NCT05550714

Recruiting 188 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-10-15
Primary completion
2024-03-26
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Desflurane Other / unclassified 0.5 unknown Inhaled
Subject Desflurane Other / unclassified 1 unknown Inhaled
Comparator Dexmedetomidine Other / unclassified 0.2 ug/kg Intravenous
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Background Cisatracurium Small molecule 0.2 mg/kg
Background Propofol Small molecule 1.5 mg/kg
Background Propofol Small molecule 2 mg/kg
Background Remifentanil Small molecule
Background Sufentanil Other / unclassified 0.1 ug/kg
Background Sufentanil Other / unclassified 0.2 ug/kg

Indications