NCT05895019 Effects of Propofol on Brain Function in Patients With Parkinson's Disease
| NCT ID | NCT05895019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | PD - Parkinson's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-06-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Obstructive sleep apnea; 2. BMI \> 30kg/m2; 3. Estimated difficult airway; 4. Patients with prior allergy to anesthetic drugs; 5. Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction); 6. Patients with craniocerebral trauma or craniocerebral operation history resulting in incomplete skull or brain parenchyma defect; 7. Patients with alcohol or drug addiction.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05895019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying PD - Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05895019 currently recruiting?
Yes, NCT05895019 is actively recruiting participants. Contact the research team at ruquan.han@gmail.com for enrollment information.
Where is the NCT05895019 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05895019 clinical trial?
NCT05895019 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 600 participants.
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