About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 65 years old, native Chinese speaker, dextromanual;
Chronic disorder of consciousness;
Spinal cord electrical stimulator implantation under general anesthesia;
Signed informed consent.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Drug: Esketamine (Continuous infusion)
DrugContinuous intravenous infusion of ketamine at a dose of 0.3mg/(kg · h). Collect resting state EEG and auditory event-related potential (ERP) before administration (baseline), 60 minutes after administration, 30 and 60 minutes after discontinuation.
Treatment groups
Trial outcomes
Primary outcomes
Entropy index.
A higher entropy index indicates a higher brain complexity.
Lempel Ziv complexity.
Higher Lempel Ziv complexity indicates higher brain complexity.
Secondary outcomes
EEG Spectral Characteristics
EEG power spectrum characteristics of pDoC patients under esketamine. administration, including the δ, θ, α, β, and γ frequency bands.
Cortical Connectivity
Characteristics of the weighted phase lag index(WPLI) in patients with pDoC. 0 ≤ WPLI ≤ 1, where 0 represents asynchronous and 1 represents synchronous.
Rate of patients recovered consciousness after surgery
Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery.
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