Clinical trial NCT05550714: Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease
Official title: Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PD - Parkinson's Disease
Dexmedetomidine
Desflurane
Deep Brain Stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 188
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).
timeFrame: 1 day (during MER recording)
Secondary outcomes:
measure: NRMS and their stratified proportions in the CS and GA groups
timeFrame: 1 day (during MER recording)
measure: Firing rates
timeFrame: 1 day (during MER recording)
measure: Lengths of STN(mm)
timeFrame: 1 day (during MER recording)
measure: Total electrode path times
timeFrame: 1 day (during MER recording)
measure: Beta band (13-30 Hz) oscillations calculated by spectrum analysis
timeFrame: 1 day (during MER recording)
measure: Proportion of intraoperative remedial measures implemented
timeFrame: 1 day (during MER recording)
measure: Duration of operation and MER
timeFrame: 1 day (during the DBS surgery)
measure: The accuracy of the DBS electrode
timeFrame: Within 24 hours after the operation
measure: Clinical efficacy measured with the improvement of the United Parkinson's Disease Rating Scale (UPDRS)-III (conditions: med on/off, stim on/off)
timeFrame: 6 months after STN-DBS
measure: Clinical efficacy measured with Levodopa equivalent daily dose (LEDD) reduction
timeFrame: 6 months after STN-DBS
measure: Cognitive function as measured by the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline and 24 hours, 2 days, 3 days and 6 months after the operation
measure: Quality of life measured with the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
timeFrame: 6 months after STN-DBS
measure: The incidence of operation-related complications
timeFrame: Up to 6 months after randomization
measure: The incidence of anaesthesia-related adverse events
timeFrame: Up to 3 days after randomization
measure: Surgical experience satisfaction 24 hours after the operation and DBS satisfaction 6 months after the operation evaluated by the seven-point Likert scale
timeFrame: 24 hours after operation for surgical experience satisfaction and 6 months after STN-DBS for DBS satisfaction
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: