Effects of Propofol on Brain Function in Patients With Parkinson's Disease

This study looks at how the anesthetic propofol affects brain function in people with Parkinson's Disease compared to those without it, to help improve anesthesia during surgery for PD patients.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05895019 on ClinicalTrials.gov

What this trial studies

This observational study investigates how propofol, a commonly used anesthetic, affects brain function in patients with Parkinson's Disease (PD) compared to non-PD patients. It aims to determine the differences in propofol dosing requirements during anesthesia induction for patients undergoing surgery. By monitoring brain activity through electroencephalography, the study seeks to provide insights into the pharmacokinetics and pharmacodynamics of propofol in this specific patient population. The findings could help optimize anesthetic management for PD patients during surgical procedures.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with a diagnosis of primary or hereditary Parkinson's Disease who are scheduled for bilateral deep brain stimulation surgery.

Not a fit: Patients with obstructive sleep apnea, significant obesity, or serious organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved anesthetic protocols for patients with Parkinson's Disease, enhancing their safety and outcomes during surgery.

How similar studies have performed: While there is limited data on propofol's effects specifically in Parkinson's patients, similar studies on anesthetic management in neurological conditions have shown promising results.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ruquan Han, MD, PhD

Conditions PD - Parkinson's Disease; Propofol; Electroencephalography; Cerebral autoregulation