Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Entropy index.
研究概览
简要总结
Prolonged disorders of consciousness (pDoC) are pathologies in which there is a loss of consciousness for more than 28 days. The number of patients with pDoC is increasing as the level of critical care treatment and monitoring improves. However, clinical trials for patients with pDoC are limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use. In recent years, ketamine has been used with remarkable success in the treatment of neuropsychiatric disorders by inducing neuroplasticity, increasing neurophysiologic complexity, and expanding functional brain connectivity states. Considering increased brain plasticity as well as brain complexity, it may be beneficial for consciousness recovery. In this study, the investigators aimed to explore the effects of esketamine on brain networks and level of consciousness in patients with pDoC, and to discuss its possible use as a wakefulness-promoting treatment for patients with pDoC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with prolonged disorders of consciousness:
- •Inclusion Criteria:
- •Age 18 - 65 years old, native Chinese speaker, dextromanual;
- •Chronic disorder of consciousness;
- •Spinal cord electrical stimulator implantation under general anesthesia;
- •Signed informed consent.
排除标准
- •Continuous sedation was administered within 72 hours prior to the study;
- •Open head injury, parenchymal resection and other damage of brain structural integrity;
- •The intracranial compliance decreased due to hydrocephalus and swelling;
- •Known hearing impairment;
- •Airway stenosis and various causes of severe ventilation or ventilation dysfunction;
- •Known or suspected severe cardiac, pulmonary, hepatic, and renal dysfunction;
- •History of drug allergy to esketamine;
- •Associated with other mental or neurological diseases;
- •Other reasons are not suitable to participate in this study.
- •Healthy brain volunteers:
- •Inclusion Criteria:
- •Age 18 - 65 years old;
- •Patients undergoing surgical treatment under elective general anaesthesia;
- •American Society of Anesthesiologists (ASA) I-II;
- •Native Chinese speaker;
- •Dextromanual;
- •Signed informed consent.
- •Exclusion Criteria:
- •Previous history of craniocerebral disease, imaging suggests organic brain lesions;
- •People with uncontrolled hypertension, hyperthyroidism, elevated intracranial pressure, epileptic seizures;
- •History of drug allergy to esketamine;
- •Hearing abnormality;
- •History of drug and alcohol abuse;
- •People with mental and behavioral disorders.
结局指标
主要结局
Entropy index.
时间窗: During the trial(up to 3 hours for each subject).
A higher entropy index indicates a higher brain complexity.
Lempel Ziv complexity.
时间窗: During the trial(up to 3 hours for each subject).
Higher Lempel Ziv complexity indicates higher brain complexity.
次要结局
- EEG Spectral Characteristics(During the trial(up to 3 hours for each subject).)
- Rate of patients recovered consciousness after surgery(During the trial(through study completion, 180 days).)
- Cortical Connectivity(During the trial(up to 3 hours for each subject.)
研究者
Ruquan Han
Head of anesthesiology, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital