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A General Anesthesia Regimen for DBS Surgery in Patients With PD

NCT06658132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson's Disease (PD)

Interventions

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2025-02-27
Completion
2025-03-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658132 on ClinicalTrials.gov