Actively Recruiting
Effects of Propofol on Brain Function in Patients With Parkinson's Disease
Led by Beijing Tiantan Hospital · Updated on 2023-06-27
600
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the anesthetic drug propofol affects brain function in patients with Parkinson's disease (PD) compared to patients without PD. Propofol is commonly used during surgery because it acts quickly and has properties that may protect the brain by reducing oxidative stress. This observational study aims to compare the amount of propofol needed to induce anesthesia and monitor changes in brain activity and blood flow regulation during surgery between PD and non-PD patients. Participants receive propofol using a target-controlled infusion pump with a starting dose adjusted until unconsciousness is reached. Propofol levels and brain function are closely monitored before, during, and after anesthesia induction, including at intubation and skin incision times. The study includes two groups: patients with Parkinson's disease undergoing bilateral deep brain stimulation surgery and non-Parkinson patients undergoing other non-neurosurgical, non-cardiac surgeries. During the study, participants will have their brain electrical activity (EEG) and cerebral blood flow autoregulation measured at various times up to three days after surgery. Researchers will also assess patient satisfaction with sedation. The main outcome is the dose of propofol used during the trial, with secondary outcomes focused on brain signal features and blood flow control. The study lasts up to three days for each participant, with multiple assessments conducted throughout this period.
CONDITIONS
Brief Title
Effects of Propofol on Brain Function in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Parkinson's group: age 18 to 80 years, ASA class I-III, planned bilateral DBS surgery
- Diagnosed with primary or hereditary Parkinson's disease responding well to levodopa
- Provided informed consent
- For non-Parkinson's group: age 18 to 80 years, ASA class I-III, planned non-neurosurgical, non-cardiac surgery
- No prior diagnosed neurological disease or dysfunction
- Provided informed consent
You will not qualify if you...
- Obstructive sleep apnea
- Body mass index (BMI) greater than 30 kg/m2
- Estimated difficult airway
- Known allergy to anesthetic drugs
- Serious heart, kidney, or liver dysfunction
- History of brain trauma or surgery causing skull or brain defects
- Alcohol or drug addiction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 minutes for each participant
Participants receive propofol anesthesia with doses adjusted to achieve unconsciousness while clinical trial data including EEG signals and cerebral autoregulation are collected during and shortly after anesthesia induction.
1 in-person visit during surgery
Duration - Up to 3 days
Participants are observed for recovery and patient satisfaction with sedation is assessed up to 3 days after the procedure.
Follow-up visits up to 3 days after surgery
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
R
Ruquan Han, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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