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A total of 270 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 2:1 with etomidate as the control group.Neither the investigators nor the subjects were aware of the group assignments. 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. Compared with etomidate, the efficacy and safety of Methoxyethyl Etomidate Hydrochloride for sedation/anesthesia in gastroscopy/colonoscopy were further evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET-26 0.8mg group | Experimental | Experimental |
|
| Etomidate group | Active Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET-26HCl 0.8mg/kg group | Drug | The initial dose was 0.8 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus) |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of gastroscopy/colonoscopy | From the time of bolus administration to the completion of gastroscopy/colonoscopy, the following two conditions were met simultaneously: (1) the number of additional doses within any 15 minutes was ≤5; (2) no use of rescue drugs. | Within approximately 1 hour 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:
patients undergoing routine gastroscopy/colonoscopy;
age ≥ 18 and ≤ 75 years old, regardless of gender;
American Society of Anesthesiologists (ASA) grade I-III;
Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;
Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator
Vital signs during screening:
respiratory rate ≥10 and ≤24 times/min; Pulse oxygen saturation (SpO2) ≥95% while breathing air; Systolic blood pressure (SBP) ≥90mmHg and ≤160mmHg; Diastolic blood pressure (DBP) ≥60mmHg and ≤100mmHg; Heart rate (ECG) ≥55 and ≤100 beats/min;
Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the trial protocol to complete the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoran Yang | Contact | 13146214840 | yangxiaoran@avancpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Mengchang Yang | Sichuan Academy of Medical Sciences | Principal Investigator |
| Jin Liu | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| Etomidate Injectable Product 0.3mg/kg group | Drug | The initial dose was 0.3 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus) |
|
The time from the first administration of the experimental drug to the MOAA/S score ≤1
| within approximately 1minute after injection |
| Duration from successful insertion to full consciousness | the time from successful insertion to full awakening (the first time of three consecutive MOAA/S scores reaching 5 points | after approximately 30 minutes of the completion of 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 50 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 60 minutes of the completion of the first injection |
| The time from the end of the endoscopic session to discharge from 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 |
| Rate of use of remedial drugs | Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more | 60minutes after injection |
| Test drug additions | the additional situation and dosage of drugs were summarized | 30minutes after injection |
| Assessment of orientation | Orientation was evaluated when MOAA/S reached 5 points for the first time after the complete withdrawal of gastroscopy/colonoscopy | 20 minutes after the end of endoscopic treatment |
| Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated | The total score is 10, that is, a score of 0 indicates very dissatisfied and a score of 10 indicates very satisfied | 60 minutes after the end of endoscopic treatment |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
|
| Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
|
| 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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