Brain Network Analysis of Anesthesia Characteristics in Patients With pDoC Based on PSG

Capital Medical University

Status: Enrolling

Conditions: Disorders of Consciousness

Treatments: Drug: General Anesthetics

Study type: Observational

Funder types: Other

Identifiers

NCT06157008

evchen99525

Details and patient eligibility

About

The goal of this prospective, exploratory and observational study is to learn about in healthy volunteers and patients with prolonged disorders of consciousness(pDoC). The main questions it aims to answer are:

1. Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography
2. To observe the similarities and differences of polysomnography in pDoC patients before and after Insertion of spinal cord electric stimulator under general anesthesia,and analyze the changes of anesthesia characteristic brain network in patients with consciousness disorders based on polysomnography.
3. To observe the similarities and differences of polysomnography in pDoC patients before and after spinal cord stimulation,and analyze the characteristic changes of brain network after spinal cord stimulation.

We will record the 8h polysomnography of healthy volunteers,record the polysomnography of DOC patients before and 24 hours after operation;and record the 24h polysomnography of patients with spinal cord electric stimulator.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Inclusion criteria of health volunteer group:

  1. Aged 18-65, native Chinese
  2. No history of sleep apnea
  3. No history of insomnia
  4. Volunteer to participate in this study and obtain informed consent.

• Inclusion criteria of pDoC group:

  1. Aged 18-65, native Chinese
  2. pDoC after acquired brain injury
  3. The spinal electric stimulator was implanted under general anesthesia
  4. Obtain informed consent.

• Exclusion Criteria:

  1. Healthy volunteers took hypnotic drugs 72 hours before the study
  2. Continuous sedation treatment was carried out within 72 hours before the study
  3. The integrity of brain structures such as open head injury and brain parenchyma resection
  4. Intracranial compliance decreased due to hydrocephalus
  5. Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
  6. Known or suspected to have serious heart, lung and kidney dysfunction
  7. Allergic history of sedative drugs
  8. Combined with other mental or nervous system diseases
  9. Other reasons are not suitable for this study.

Trial design

60 participants in 2 patient groups

healthy volunteers

patients with prolonged disorders of consciousness

Treatment:

Drug: General Anesthetics