A total of 78 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 1:1:1 with etomidate as the control group, 26 cases in each group. All subjects were blinded to treatment allocation. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. To preliminarily evaluate the efficacy and safety of ET-26 in gastroscopy/colonoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
78
The initial dose is 0.6 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.
The initial dose is 0.8 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.
The initial dose is 0.3 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion).Infusion time was 1minute ± 5second.
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Guangyuan First People's Hospital
Guangyuan, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Success rate of gastroscopy/colonoscopy
Number of appends ≤5; No alternative medications or other sedatives/anesthetics were used from the beginning of the first dose of the trial product until the completion of gastroscopy/colonoscopy.
Time frame: within approximately 15minutes after injection
Sedation/anesthesia success rate
Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug
Time frame: Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia
The time from the first administration of the experimental drug to the MOAA/S score ≤1
Time frame: within approximately 1minute after injection
Insertion duration
The time between initial administration of the investigational drug and successful insertion of the lens
Time frame: within approximately 7minutes after the first injection
Success rate of lens insertion
Percentage of subjects with successful insertion
Time frame: within approximately 7minutes after the last injection
Duration from completion of experimental drug administration to full recovery
The time between the completion of the last trial drug administration and the subject's full recovery (the first of three consecutive MOAA/S scores of 5)
Time frame: Within approximately 30 minutes of the completion of the last injection
The time from the end of treatment to full consciousness
The time from gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5)
Time frame: Within approximately 30 minutes of the completion of the first injection
Duration from the end of treatment to the end of the room
The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9
Time frame: A maximum of 10 minutes after awakening
The time when BIS reaches 60 or below
The period from the beginning of first dosing of the investigational product to the first BIS of 60 or less
Time frame: within approximately 5minutes after injection
The length of BIS between 40 and 60
Duration of BIS values between 40 and 60, including boundary values
Time frame: within 7minutes after injection
Rate of use of remedial drugs
Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more
Time frame: within 60minutes after injection
Test drug additions
the additional situation and dosage of drugs were summarized
Time frame: within 30minutes after injection
Cognitive function evaluation
Mini-mental State Examination
Time frame: Maximum 40 minutes after awakening
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