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NCT Number: NCT05895019

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

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.

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Key information

Conditions

PD - Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-59976660

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Propofol Dose

    Time frame: 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 outcomes

  1. Feature extraction of EEG Signals

    Time frame: 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

  2. Feature Extraction of EEG Signals

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

    To compare the EEG power in delta、theta、alpha and beta band

  3. Cerebral Autoregulation

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

    The mean velocity of the middle cerebral artery，transient hyperemic response ratio

  4. Patient Satisfaction with Sedation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, MD, PhD

CONTACT

[email protected]

8610-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2023
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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