PD - Parkinson's DiseaseNCT05895019
Effects of Propofol on Brain Function in Patients With Parkinson's Disease
An observational study of PD - Parkinson's Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Propofol is a short-acting general anesthetic drug commonly used in clinical practice, with rapid clinical onset of action, amnesic, anxiolytic, antiepileptic, and muscle relaxant effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PD - Parkinson's Disease
- What is being tested?
- Propofol
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Sep 2026
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: PD group: (1) age 18-80 years, ASA class I-III, proposed bilateral DBS surgery; (2) primary PD, or hereditary PD, various genotypes of PD, responding well to compounded levodopa; (3) informed consent obtained; Non-PD group: (1) age 18-80 years, ASA class I-III, proposed non-neurosurgical non-cardiac surgery; (2) no previous clearly diagnosed neurological disease or neurological dysfunction; (3) informed consent obtained.
Who may be able to join
- PD group:
- age 18-80 years, ASA class I-III, proposed bilateral DBS surgery;
- primary PD, or hereditary PD, various genotypes of PD, responding well to compounded levodopa;
- informed consent obtained;
- Non-PD group:
- age 18-80 years, ASA class I-III, proposed non-neurosurgical non-cardiac surgery;
- no previous clearly diagnosed neurological disease or neurological dysfunction;
- informed consent obtained.
Who cannot join
- Obstructive sleep apnea;
- BMI > 30kg/m2;
- Estimated difficult airway;
- Patients with prior allergy to anesthetic drugs;
- Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction);
- Patients with craniocerebral trauma or craniocerebral operation history resulting in incomplete skull or brain parenchyma defect;
- Patients with alcohol or drug addiction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
About this study
Propofol is a short-acting general anesthetic drug commonly used in clinical practice, with rapid clinical onset of action, amnesic, anxiolytic, antiepileptic, and muscle relaxant effects. The lack of natural antioxidants in patients with Parkinson's disease and propofol's ability to protect the brain by inhibiting oxidative stress, its pharmacokinetic and pharmacodynamic properties make propofol a suitable anesthetic drug for functional stereotactic surgery in patients with Parkinson's disease. However, changes in brain functional status during propofol anesthesia in Parkinson's patients are unknown. There is a lack of data from extensive clinical studies to support the need for propofol dosing during induction of anesthesia compared with non-Parkinson patients. This study is a prospective cohort study designed to compare the differences in propofol dosing requirements during induction of propofol anesthesia in patients with PD versus non-PD and to monitor the characteristics of altered brain functional status such as EEG and cerebral blood flow autoregulation capacity in PD versus non-PD patients during the perioperative period.
- Conditions
- PD - Parkinson's Disease
- Being tested
- Propofol
- Keywords
- Propofol, Electroencephalography, Cerebral autoregulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol was administered using TCI pump induction with a starting target effect concentration of 1.0ug/ml. The target concentration was increased by 0.2-0.5ug/ml if the patient did not reach unconsciousness after 1 min of stabilization of the target concentration. The propofol concentration recorded at this time was the target concentration the patient was induced to unconsciousness. The state of consciousness was tested every 60 s by the investigator, and clinical trial data were collected for 5 min; after that, clinical trial data were recorded before and after induction of anesthesia at 5 min after induction of anesthesia, at intubation and skin dissection, and 1, 3, and 5 min after intubation and skin dissection, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's disease | Patients with Parkinson's disease Receives: Drug: Propofol | |
| Non-Parkinson's patients | Non-Parkinson's patients Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol Dose
Differences in propofol dose required during induction of propofol anesthesia in Parkinson's disease versus non-Parkinson's disease patients
Measured: During the trial(up to 30 minutes for each subject)
Secondary outcomes (4)
Feature extraction of EEG Signals
To compare the correlation between OAA/S sedation scores and EEG and its quantitative indexes
Measured: During the trial(up to 3 hours for each subject)
Feature Extraction of EEG Signals
To compare the EEG power in delta、theta、alpha and beta band
Measured: During the trial(up to 3 days for each subject)
Cerebral Autoregulation
The mean velocity of the middle cerebral artery，transient hyperemic response ratio
Measured: During the trial(up to 3hours for each subject)
Patient Satisfaction with Sedation
to assess patient satisfaction with sedation and the occurrence of adverse events during sedation on a four-level scale.
Measured: During the trial(up to 3 days for each subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD - Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895019
- Sponsor's protocol ID
- ywn20220901
- Status last verified
- Jun 2023
- First submitted
- 2 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propofol on Brain Function in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05895019
- Acronym / sponsor ID
- ywn20220901
- Conditions
- PD - Parkinson's Disease
- Keywords
- Propofol, Electroencephalography, Cerebral autoregulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Jun 2023 (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.
Propofol is a short-acting general anesthetic drug commonly used in clinical practice, with rapid clinical onset of action, amnesic, anxiolytic, antiepileptic, and muscle relaxant effects. The lack of natural antioxidants in patients with Parkinson's disease and propofol's ability to protect the brain by inhibiting oxidative stress, its pharmacokinetic and pharmacodynamic properties make propofol a suitable anesthetic drug for functional stereotactic surgery in patients with Parkinson's disease. However, changes in brain functional status during propofol anesthesia in Parkinson's patients are unknown. There is a lack of data from extensive clinical studies to support the need for propofol dosing during induction of anesthesia compared with non-Parkinson patients. This study is a prospective cohort study designed to compare the differences in propofol dosing requirements during induction of propofol anesthesia in patients with PD versus non-PD and to monitor the characteristics of altered brain functional status such as EEG and cerebral blood flow autoregulation capacity in PD versus non-PD patients during the perioperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's disease | – | Drug: PropofolPatients with Parkinson's disease |
| Non-Parkinson's patients | – | Drug: PropofolNon-Parkinson's patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- PD group: (1) age 18-80 years, ASA class I-III, proposed bilateral DBS surgery; (2) primary PD, or hereditary PD, various genotypes of PD, responding well to compounded levodopa; (3) informed consent obtained; Non-PD group: (1) age 18-80 years, ASA class I-III, proposed non-neurosurgical non-cardiac surgery; (2) no previous clearly diagnosed neurological disease or neurological dysfunction; (3) informed consent obtained.
Key inclusion criteria (8 listed)
- age 18-80 years, ASA class I-III, proposed bilateral DBS surgery;
- primary PD, or hereditary PD, various genotypes of PD, responding well to compounded levodopa;
- informed consent obtained;
- age 18-80 years, ASA class I-III, proposed non-neurosurgical non-cardiac surgery;
- no previous clearly diagnosed neurological disease or neurological dysfunction;
Key exclusion criteria (7 listed)
- Obstructive sleep apnea;
- BMI > 30kg/m2;
- Estimated difficult airway;
- Patients with prior allergy to anesthetic drugs;
- Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction);
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 |
|---|---|---|
| PropofolPropofol was administered using TCI pump induction with a starting target effect concentration of 1.0ug/ml. The target concentration was increased by 0.2-0.5ug/ml if the patient did not reach unconsciousness after 1 min of stabilization of the target concentration. The propofol concentration recorded at this time was the target concentration the patient was induced to unconsciousness. The state of consciousness was tested every 60 s by the investigator, and clinical trial data were collected for 5 min; after that, clinical trial data were recorded before and after induction of anesthesia at 5 min after induction of anesthesia, at intubation and skin dissection, and 1, 3, and 5 min after intubation and skin dissection, respectively. | Drug | Non-Parkinson's patients, Patients with Parkinson's disease |
Primary outcome
Propofol Dose
Time frame: During the trial(up to 30 minutes for each subject)
Differences in propofol dose required during induction of propofol anesthesia in Parkinson's disease versus non-Parkinson's disease patients
4 secondary outcomes
Feature extraction of EEG Signals
Time frame: During the trial(up to 3 hours for each subject)
Feature Extraction of EEG Signals
Time frame: During the trial(up to 3 days for each subject)
Cerebral Autoregulation
Time frame: During the trial(up to 3hours for each subject)
Patient Satisfaction with Sedation
Time frame: During the trial(up to 3 days for each subject)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PD - Parkinson's Disease, run by Beijing Tiantan 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 8 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, MD, PhD (8610-59976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol Dose (time frame: During the trial(up to 30 minutes for each subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2023.