This is a multicenter, randomized, double-blind, etomidate-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between ET-26 and etomidate in the induction of general anesthesia in subjects undergoing elective surgery, so as to provide a reference for the marketing registration of methoetomidate hydrochloride for injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
freeze-dried powder injection,The initial dose is 0.8 mg/kg, with an additional 50% starting dose if needed. single dose, Infusion time was 60s ± 5s.
lipid emulsion ,The initial dose is 0.3 mg/kg, with an additional 50% starting dose if needed.single dose, Infusion time was 60s ± 5s.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGSuccess rate of anesthesia induction
modified observer's assessment of alert≤1 (only one additional dose was allowed) and endotracheal intubation was completed within 7 minutes from the beginning of study drug infusion, and no remedial drugs were used
Time frame: within 7minutes after injection
Time to loss of consciousness
Time frame: Time from first administration of study drug to MOAA/S(modified observer's assessment of alert)≤1,every 1 minute ±5 seconds, within 3 minutes after injection
The percentage of time between 40≤BIS(Bispectral index)≤60
Time frame: During the period from the initial administration to the successful intubation of the tracheal tube,every 1 minute±20 seconds, within 7minutes after injection
The percentage of subjects with eyelash reflexes disappearing
Time frame: within 3 minutes after injection
time required to achieve eyelash reflex disappearance
Time frame: within 3 minutes after injection
the use of investigational drugs and remedial drugs
Time frame: Induction period of anesthesia,within 7minutes after injection
Proportion of subjects using remedial sedatives
Time frame: Induction period of anesthesia,within 7minutes after injection
The time to successfully intubate
Time frame: within 7minutes after injection
intubation reaction
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Whether coughing, body movement reaction
Time frame: within 5 minutes after successful intubation
Changes of BIS(Bispectral index) within 30 minutes after endotracheal intubation successfully (such as the time percentage between BIS 40 and BIS 60)
Time frame: 30 minutes after successful intubation
Anesthesiologists' satisfaction scores on the transition between induction and maintenance of anesthesia.
The anesthesiologist's satisfaction score for the connection between induction of anesthesia and maintenance of anesthesia, on a scale of 10, 0 being very dissatisfied and 10 being very satisfied.
Time frame: immediately after surgery