Parkinson's Disease (PD)GADBSNCT06658132
A General Anesthesia Regimen for DBS Surgery in Patients With PD
A study testing 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery. in people with Parkinson's Disease (PD), run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: 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.
Read more
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)
- Being tested
- 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery.
- Keywords
- deep brain electrical stimulation, a general anesthesia regimen, esketamine, remifentanil, Parkinson's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery.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.
| Study group | Role | What they receive |
|---|---|---|
| remifentanil combined with esketamine | Experimental | a novel anesthesia regimen of remifentanil combined with esketamine for the physiological testing phase of DBS surgery. Receives: Drug: 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of MER signal recordings with high NRMS.
Mean NRMS greater than 2.0 after MER recording after STN entry.
Measured: During surgery
Secondary outcomes (7)
MER signal strength
Measured: During surgery
Beta band (13-30Hz) oscillations calculated by spectrum analysis during MER recording.
Measured: During surgery
Length of STN
Measured: During surgery
Proportion of successfully defining STN borders
Measured: During surgery
occurrence of cognitive impairment at 7 days postoperatively
MoCA scale score decreased by 2 points compared with preoperatively
Measured: at 7 days postoperatively
occurrence of depression at 7 days postoperatively
HAMD scale score> 20 points
Measured: at 7 days postoperatively
Patient satisfaction at 24 hours after surgery
Analyzed by patient satisfaction assessment scale.
Measured: at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start29 Oct 2024
- Primary completion27 Feb 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658132
- Sponsor's protocol ID
- Anesthesia Methods for DBS
- Acronym
- GADBS
- Status last verified
- May 2025
- First submitted
- 23 Oct 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang D, Luo H, Shu H, Wang R, Zhang Y, Guo L, Ma J, Zhou H, Tian J. Remifentanil-esketamine-based General Anesthesia Strategy for Microelectrode-guided Deep-brain Stimulation for Parkinson Disease. Anesthesiology. 2026 Apr 1;144(4):1021-1024. doi: 10.1097/ALN.0000000000005929. Epub 2026 Feb 13. No abstract available.
PubMed 41685788
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of a General Anesthesia Regimen for Deep Brain Electrical Stimulation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06658132
- Acronym / sponsor ID
- GADBS / Anesthesia Methods for DBS
- Conditions
- Parkinson's Disease (PD)
- Keywords
- deep brain electrical stimulation, a general anesthesia regimen, esketamine, remifentanil, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| remifentanil combined with esketamine | Experimental | Drug: 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery.a novel anesthesia regimen of remifentanil combined with esketamine for the physiological testing phase of DBS surgery. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | remifentanil combined with esketamine |
Primary outcome
Proportion of MER signal recordings with high NRMS.
Time frame: During surgery
Mean NRMS greater than 2.0 after MER recording after STN entry.
7 secondary outcomes
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
Time frame: at 7 days postoperatively
occurrence of depression at 7 days postoperatively
Time frame: at 7 days postoperatively
Patient satisfaction at 24 hours after surgery
Time frame: at 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41685788Huang D, Luo H, Shu H, Wang R, Zhang Y, Guo L, Ma J, Zhou H, Tian J. Remifentanil-esketamine-based General Anesthesia Strategy for Microelectrode-guided Deep-brain Stimulation for Parkinson Disease. Anesthesiology. 2026 Apr 1;144(4):1021-1024. doi: 10.1097/ALN.0000000000005929. Epub 2026 Feb 13. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5~1ug/kg/min remifentanil combined with 0.2~0.5mg/kg/h esketamine for the physiological testing phase of DBS surgery. in people with Parkinson's Disease (PD), run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of MER signal recordings with high NRMS. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.