Effects of Propofol on Brain Function in Patients With Parkinson's Disease
ConditionPD - Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Obstructive sleep apnea;
BMI > 30kg/m2;
Estimated difficult airway;
Patients with prior allergy to anesthetic drugs;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Propofol
DrugPropofol 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Patients with Parkinson's disease1 intervention
Group B: Non-Parkinson's patients1 intervention
Trial outcomes
Primary outcomes
1
Propofol Dose
Differences in propofol dose required during induction of propofol anesthesia in Parkinson's disease versus non-Parkinson's disease patients
Time frame
During the trial(up to 30 minutes for each subject)Secondary outcomes
1
Feature extraction of EEG Signals
To compare the correlation between OAA/S sedation scores and EEG and its quantitative indexes
Time frame
During the trial(up to 3 hours for each subject)2
Feature Extraction of EEG Signals
To compare the EEG power in delta、theta、alpha and beta band
Time frame
During the trial(up to 3 days for each subject)3
Cerebral Autoregulation
The mean velocity of the middle cerebral artery，transient hyperemic response ratio
Time frame
During the trial(up to 3hours for each subject)4
Patient Satisfaction with Sedation
to assess patient satisfaction with sedation and the occurrence of adverse events during sedation on a four-level scale.
Time frame
During the trial(up to 3 days for each subject)Sponsors and contacts
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Source ClinicalTrials.gov