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

Recruiting

• Conditions: PD - Parkinson's Disease
• Interventions: Drug: Propofol

• Registration Number: NCT05895019
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-30
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Posted: 2023-06-08
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Parkinson's disease	Propofol	Patients with Parkinson's disease
Non-Parkinson's patients	Propofol	Non-Parkinson's patients

Primary Outcome Measures

Name	Time	Method
Propofol Dose	During the trial(up to 30 minutes for each subject)	Differences in propofol dose required during induction of propofol anesthesia in Parkinson's disease versus non-Parkinson's disease patients

Secondary Outcome Measures

Name	Time	Method
Cerebral Autoregulation	During the trial(up to 3hours for each subject)	The mean velocity of the middle cerebral artery，transient hyperemic response ratio
Feature extraction of EEG Signals	During the trial(up to 3 hours for each subject)	To compare the correlation between OAA/S sedation scores and EEG and its quantitative indexes
Patient Satisfaction with Sedation	During the trial(up to 3 days for each subject)	to assess patient satisfaction with sedation and the occurrence of adverse events during sedation on a four-level scale.
Feature Extraction of EEG Signals	During the trial(up to 3 days for each subject)	To compare the EEG power in delta、theta、alpha and beta band

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China