Clinical trial NCT05895019: Effects of Propofol on Brain Function in Patients With Parkinson's Disease
Official title: Effects of Propofol on Brain Function in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PD - Parkinson's Disease
Keywords: Propofol
Electroencephalography
Cerebral autoregulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Primary outcomes:
measure: Propofol Dose
timeFrame: During the trial(up to 30 minutes for each subject)
Secondary outcomes:
measure: Feature extraction of EEG Signals
timeFrame: During the trial(up to 3 hours for each subject)
measure: Feature Extraction of EEG Signals
timeFrame: During the trial(up to 3 days for each subject)
measure: Cerebral Autoregulation
timeFrame: During the trial(up to 3hours for each subject)
measure: Patient Satisfaction with Sedation
timeFrame: During the trial(up to 3 days for each subject)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: