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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
Continuous 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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
RECRUITINGEntropy index.
A higher entropy index indicates a higher brain complexity.
Time frame: During the trial(up to 3 hours for each subject).
Lempel Ziv complexity.
Higher Lempel Ziv complexity indicates higher brain complexity.
Time frame: During the trial(up to 3 hours for each subject).
EEG Spectral Characteristics
EEG power spectrum characteristics of pDoC patients under esketamine. administration, including the δ, θ, α, β, and γ frequency bands.
Time frame: During the trial(up to 3 hours for each subject).
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.
Time frame: During the trial(up to 3 hours for each subject.
Rate of patients recovered consciousness after surgery
Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery.
Time frame: During the trial(through study completion, 180 days).
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