16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg. All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, China
Pharmacokinetic parameters
Cmax
Time frame: up to 24 hours after infusion
Pharmacokinetic parameters
Tmax
Time frame: up to 6 hours after infusion
Pharmacokinetic parameters
T1/2
Time frame: up to 12 hours after infusion
Pharmacokinetic parameters
AUC0-t
Time frame: immediately after infusion to 24 hours after infusion
Pharmacodynamic indicators
modified observer's assessment of alert(MOAA/S) score: The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness
Time frame: MOAA/S score was measured within 60 minutes before administration, was performed every 1 minute±5second within 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration
Pharmacodynamic indicators
bispectral index: BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition.
Time frame: BIS score was measured within 60 minutes before administration as baseline value,was performed every 1 minute±5second within 5minutes of administration and every 2minutes±30seconds after 5minutes of administration
Pharmacodynamic indicators:Eyelash reflex
When the anesthesiologist touches the eyelashes with the anterior fibers of the cotton swab, it can cause the blink of the examined person, that is, there is an eyelash reflex. If the reaction disappears, the depth of anesthesia is judged to reach the degree of loss of consciousness
Time frame: every 1 minute± 5seconds during the first 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration
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