A General Anesthesia Regimen for DBS Surgery in Patients With PD (GADBS)

May 15, 2025 updated by: Jie Tian, RenJi Hospital

An Exploratory Study of a General Anesthesia Regimen for Deep Brain Electrical Stimulation in Patients With Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remifentanil combined with esketamine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of MER signal recordings with high NRMS.
Time Frame: During surgery
Mean NRMS greater than 2.0 after MER recording after STN entry.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MER signal strength
Time Frame: During surgery
During surgery
Beta band (13-30Hz) oscillations calculated by spectrum analysis during MER recording.
Time Frame: During surgery
During surgery
Length of STN
Time Frame: During surgery
During surgery
occurrence of cognitive impairment at 7 days postoperatively
Time Frame: at 7 days postoperatively
MoCA scale score decreased by 2 points compared with preoperatively
at 7 days postoperatively
occurrence of depression at 7 days postoperatively
Time Frame: at 7 days postoperatively
HAMD scale score> 20 points
at 7 days postoperatively
Patient satisfaction at 24 hours after surgery
Time Frame: at 24 hours after surgery
Analyzed by patient satisfaction assessment scale.
at 24 hours after surgery
Proportion of successfully defining STN borders
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Actual)

February 27, 2025

Study Completion (Actual)

March 5, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anesthesia Methods for DBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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