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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET-26 0.6 mg group | Experimental | 0.6mg/kg |
|
| ET-26 0.8mg group | Experimental | 0.8mg/kg |
|
| Etomidate group | Active Comparator | 0.3mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET-26HCl 0.6mg/kg group | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within approximately 15minutes after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation/anesthesia success rate | Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug | Within approximately 1 minute of the end of the injection |
| Duration of successful sedation/anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mengchang Yang | Sichuan Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital | Chengdu | Sichuan | China | |||
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|
| ET-26HCl 0.8mg/kg group | Drug | 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. |
|
|
| Etomidate Injectable Product 0.3mg/kg group | Drug | 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. |
|
|
The time from the first administration of the experimental drug to the MOAA/S score ≤1
| within approximately 1minute after injection |
| Insertion duration | The time between initial administration of the investigational drug and successful insertion of the lens | within approximately 7minutes after the first injection |
| Success rate of lens insertion | Percentage of subjects with successful insertion | 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) | 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) | 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 | 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 | within approximately 5minutes after injection |
| The length of BIS between 40 and 60 | Duration of BIS values between 40 and 60, including boundary values | 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 | within 60minutes after injection |
| Test drug additions | the additional situation and dosage of drugs were summarized | within 30minutes after injection |
| Cognitive function evaluation | Mini-mental State Examination | Maximum 40 minutes after awakening |
| Guangyuan First People's Hospital |
| Guangyuan |
| Sichuan |
| 628017 |
| China |
| Yibin Second People's Hospital | Yibin | Sichuan | 644000 | China |
| ID | Term |
|---|---|
| C000621869 | ET-26 compound |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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