An interventional study of 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery. in Parkinson's Disease (PD), sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
Patients who meet the enrollment criteria and voluntarily join this study will be admitted to the operating room on the day of surgery, and will receive endotracheal intubation under general anesthesia. Induction will be conducted with sufentanil 0.2\~0.3ug/kg, rocuronium bromide 0.6mg/kg and propofol 1\~2 mg/kg. After successful intubation, mechanical ventilation will be provided with a fresh air flow of 2.0 L/min, a tidal volume of 6\~8ml/kg and a respiratory rate of 10\~12 times/min to control the end-tidal carbon dioxide between 35\~45mmHg. Following that, 20 ml of 0.5% ropivacaine will be applied for bilateral scalp nerve block. The surgeon will then install the stereotactic head frame and take the patients out for CT examination. After returning to the operating room after CT examination, the surgeons will install driving electrodes. During this period, GA will be maintained with sevoflurane, propofol, remifentanil and rocuronium bromide. The depth of anesthesia is monitored using BIS, with a target of 40-65.
During electrode implantation stage: sevoflurane, propofol and rocuronium bromide will be stopped, and esketamine 0.2\~0.5mg/kg/h combined with remifentanil 0.5\~1ug/kg/min will be used to maintain anesthesia with a target BIS value of 60-70. Patients' blood pressure and heart rate will be controlled to change within less than 30% of the basal value with necessary medication.
If the patient moves during the electrode implantation stage, the rescue plan is to quickly inhale sevoflurane to 0.3 mac, and the number of rescues will be recorded. The vital signs of the patient, MER signal strength, STN discharge frequency, length of STN localization nucleus, and whether the STN boundary is successfully located will be recorded.
During the implantation stage of the pulser, the GA regimen will return to before electrode implantation stage. In other words, sevoflurane + remifentanil + propofol + rocuronium bromide will be used to maintain the depth of anesthesia till the end of the operation.
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This study's enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
a novel anesthesia regimen of remifentanil combined with esketamine for the physiological testing phase of DBS surgery.
Drug: 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery.
Throughout the first and third stages of surgery, all patients receive a traditional induction of anesthesia. Fifteen minutes before the second stage of surgery (MER and clinical assessment), when the burr hole is ready, the propofol and sevoflurane infusion is discontinued, and patients receive 0.5\~1ug/kg/min remifentanil combined with 0.2\~0.5mg/kg/h esketamine. On completion of the second stage of surgery, the interventional drug is discontinued and propofol combined with sevoflurane is resumed until the end of the third stage.
Proportion of MER signal recordings with high NRMS.
Mean NRMS greater than 2.0 after MER recording after STN entry.
Time frame: During surgery
MER signal strength
Time frame: During surgery
Beta band (13-30Hz) oscillations calculated by spectrum analysis during MER recording.
Time frame: During surgery
Length of STN
Time frame: During surgery
Proportion of successfully defining STN borders
Time frame: During surgery
occurrence of cognitive impairment at 7 days postoperatively
MoCA scale score decreased by 2 points compared with preoperatively
Time frame: at 7 days postoperatively
occurrence of depression at 7 days postoperatively
HAMD scale score\> 20 points
Time frame: at 7 days postoperatively
Patient satisfaction at 24 hours after surgery
Analyzed by patient satisfaction assessment scale.
Time frame: at 24 hours after surgery
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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RenJi Hospital