Thinking of joining a study?

Register your interest

NCT05550714 | Recruiting | PD - Parkinson's Disease


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

Beijing Tia Ntanhospital

Information provided by (Responsible Party):

Ru Quanhan

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.

Condition or disease

PD - Parkinson's Disease

Dexmedetomidine

Desflurane

Deep Brain Stimulation

Intervention/treatment

general anesthesia

Conscious sedation

Phase

Not Applicable

Detailed Description:

STN-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. At present, there are some studies on the effects of desflurane on neuronal signal amplitude and discharge characteristics during STN-DBS in PD patients but there is no definite conclusion. This study compares the influence of MER mapping during STN-DBS and the differences in postoperative clinical outcomes between desflurane general anesthesia and conscious sedation anesthesia to explore alternative anesthesia for DBS in PD patients who cannot tolerate local anesthesia or conscious sedation and to provide feasible anesthesia techniques for the application of MER during DBS under general anesthesia. 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). 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), which is used to compare the differences in neuronal electrical activities between conscious sedation and general anesthesia via desflurane groups. The secondary outcomes are the NRMS, length of the subthalamic nucleus, number of MER tracks, and differences in clinical outcomes 6 months after the operation.}}

Study Type : Interventional
Estimated Enrollment : 188 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION):A Randomized Controlled, Non-Inferiority Study
Actual Study Start Date : October 15, 2022
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : October 31, 2024
Arm Intervention/treatment

Experimental: General anesthesia

Drug: general anesthesia

Active Comparator: Conscious sedation

Drug: Conscious sedation

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • Obstructive sleep apnea;
  • BMI > 30kg/m2;
  • Estimated difficult airway;
  • Severe preoperative anxiety;
  • Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction)
  • A history of allergy to the anaesthetics.

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

China,

Beijing Tiantan Hospital, Capital Medical University

Beijing, China, 100070

Loading...