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

PD - Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895019
• Other study ID #: ywn20220901
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2023
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, MD, PhD
• Phone: 8610-59976660
• Email: ruquan.han[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• PD - Parkinson's Disease

Intervention

Drug:
• Propofol
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

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