Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography

Beijing Tiantan Hospital1 site in 1 country60 target enrollmentJanuary 11, 2023

ConditionsDisorders of Consciousness

InterventionsGeneral Anesthetics

Overview

Phase: N/A
Intervention: General Anesthetics
Conditions: Disorders of Consciousness
Sponsor: Beijing Tiantan Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Characteristics of sleep in pDoC patients
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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:

Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography
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.
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.

Registry

clinicaltrials.gov

Start Date

January 11, 2023

End Date

June 1, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Beijing Tiantan Hospital

Responsible Party

Principal Investigator

Ruquan Han

professor

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria of health volunteer group:
•Aged 18-65, native Chinese
•No history of sleep apnea
•No history of insomnia
•Volunteer to participate in this study and obtain informed consent.
•Inclusion criteria of pDoC group:
•Aged 18-65, native Chinese
•pDoC after acquired brain injury
•The spinal electric stimulator was implanted under general anesthesia
•Obtain informed consent.

Exclusion Criteria

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