Effects of Propofol on Brain Function in Patients With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol.
- Who it may be relevant to
- Registry conditions: PD - Parkinson's Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Propofol
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
Primary outcome measures
- Propofol Dose [Time frame: During the trial(up to 30 minutes for each subject)]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tiantan Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT05895019 · ywn20220901