A General Anesthesia Regimen for DBS Surgery in Patients With PD

NCT ID: NCT06658132

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2025-03-05

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

remifentanil combined with esketamine

a novel anesthesia regimen of remifentanil combined with esketamine for the physiological testing phase of DBS surgery.

Group Type: EXPERIMENTAL

0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery.

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Bilateral STN-DBS surgery is planned for primary PD (meeting the International Movement Disorder Society (MDS) diagnostic criteria for PD);
• ASA Classes I-III;
• Age 50-75 years;
• Informed consent from patients or their families

Exclusion Criteria

• BMI≥28.0kg/m2；
• comorbid other conditions causing parkinson-like motor symptoms;
• Previous history of severe head trauma, deformity, or craniocerebral surgery;
• Previous history of psychiatric and neurological diseases, such as history of overt stroke (ischemic lesion near STN), depression, severe central nervous system depression, basal gangliopathy, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.;
• Preoperative MoCA scale showed that the patient had dementia;
• Severe heart, liver, lung, kidney, and immune system diseases;
• Allergy or contraindication to the trial drug

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jie Tian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Anesthesia Methods for DBS

Identifier Type: -

Identifier Source: org_study_id