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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug ET-26 | Experimental |
| |
| Drug Etomidate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET-26 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success 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 | within 7minutes after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Time to loss of consciousness | 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 | During the period from the initial administration to the successful intubation of the tracheal tube,every 1 minute±20 seconds, within 7minutes after injection |
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Inclusion Criteria:
Exclusion Criteria:
1) AST and /or ALT ≥ 3×ULN; 2)TBIL≥1.5×ULN; 3) Hb≤90 g/L (and no blood transfusion within 14 days); 4)ANC≤1.5×109/L; 5)PLT≤80×109/L; 6) Blood Serum creatinine ≥1.5×ULN; 8. Pregnant and lactating women; the reluctance of fertile women or men to use contraception throughout the trial; subjects (including male subjects) who had pregnancy plans within three months of the trial; 9. Subjects who have any other factors deemed unsuitable for participation in this study by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WEIYI ZHANG, Medicine Doctor | Contact | 18980601837 | 610041 | 1370461@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| JIN LIU, Medicine Doctor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Etomidate Injectable Emulsion | Drug | 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. |
|
| The percentage of subjects with eyelash reflexes disappearing | within 3 minutes after injection |
| time required to achieve eyelash reflex disappearance | within 3 minutes after injection |
| the use of investigational drugs and remedial drugs | Induction period of anesthesia,within 7minutes after injection |
| Proportion of subjects using remedial sedatives | Induction period of anesthesia,within 7minutes after injection |
| The time to successfully intubate | within 7minutes after injection |
| intubation reaction | Whether coughing, body movement reaction | 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) | 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. | immediately after surgery |