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

NCT05895019 | Recruiting DMC

• 1 other identifier: ywn20220901
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

PD - Parkinson's Disease

Keywords

Propofol; Electroencephalography; Cerebral autoregulation

Outcome Measures

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

  During the trial(up to 30 minutes for each subject)

Secondary Outcomes (4)

• Feature extraction of EEG Signals

  During the trial(up to 3 hours for each subject)

• Feature Extraction of EEG Signals

  During the trial(up to 3 days for each subject)

• Cerebral Autoregulation

  During the trial(up to 3hours for each subject)

• Patient Satisfaction with Sedation

  During the trial(up to 3 days for each subject)

Study Arms (2)

Patients with Parkinson's disease

Patients with Parkinson's disease

Drug: Propofol

Non-Parkinson's patients

Non-Parkinson's patients

Drug: Propofol

Interventions

Propofol DRUG

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 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.

Non-Parkinson's patients; Patients with Parkinson's disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Propofol

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ruquan Han, MD, PhD

CONTACT

8610-59976660; ruquan.han@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CN (1)