Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Obstructive sleep apnea;
BMI > 30kg/m2;
Estimated difficult airway;
Severe preoperative anxiety;
Trial design
Design model
Parallel
Treatments tested in this trial
general anesthesia
DrugThe patients did not use any preoperative sedative drugs and were given sufentanil citrate 0.1-0.2 µg/kg, cisatracurium 0.2 mg/kg and propofol 1.5-2.0 mg/kg during anesthesia induction. After the patients were unconscious, oral endotracheal intubation was performed. Anesthesiologists should continuously monitor PetCO2 and maintain PetCO2 at 30-35 mmHg. During the operation, patients are treated with remifentanil, cisatracurium, and desflurane inhalation at 0.5-1.0 minimum alveolar concentration (MAC). In the MER process, the desflurane concentration is adjusted to maintain 0.5-0.6 MAC. If the desflurane concentration needs to be adjusted to less than 0.5 MAC during MER for various reasons, remedial measures will be implemented.
Conscious sedation
DrugA loading dose of DEX 0.5 µg/kg was infused intravenously at a constant speed within 15 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.2-0.5 µg/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. Maintain the BIS value at 60-80.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: General anesthesiaExperimental treatment 1 intervention
Group B: Conscious sedationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN.
Time frame
1 day (during MER recording)Secondary outcomes
1
NRMS and their stratified proportions in the CS and GA groups
We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN. We will stratify the mean NRMS of the two groups at the level of 0.5, and calculate the stratified proportions.
Time frame
1 day (during MER recording)2
Firing rates
The firing rates will be calculated using customized scripts developed from the Osort toolbox.
Time frame
1 day (during MER recording)3
Lengths of STN(mm)
The STN pass length is determined as the distance from entry to exit of the STN based on the significant, clear increase in baseline unit activity and FR changes unique to STN.
Time frame
1 day (during MER recording)4
Total electrode path times
Total electrode path times are the total number of paths actually selected, which can be used as an indirect indicator to judge the accuracy of positioning.
Time frame
1 day (during MER recording)Sponsors and contacts
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Source ClinicalTrials.gov