A Clinical Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy

Ahon Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Gastroscopy; Colonoscopy

Treatments: Drug: ET-26HCl 0.8mg/kg group; Drug: Etomidate Injectable Product 0.3mg/kg group

Study type: Interventional

Funder types: Other

Identifiers

NCT06858852

ET-26-HCl-302

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients undergoing routine gastroscopy/colonoscopy;

2. age ≥ 18 and ≤ 75 years old, regardless of gender;

3. American Society of Anesthesiologists (ASA) grade I-III;

4. Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;

5. Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator

6. 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;

7. 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

1. patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
2. patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;
3. Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);
4. having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
5. QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;
6. use of any of the following drugs or treatments before screening:1) enrolled in a clinical trial of any drug within 1 month before screening; 2) use of medications or treatments that affect cortical function within 3 days before screening; 3) Use of medications that may affect QT interval within 2 weeks before screening;
7. During the screening period, the laboratory examination indicators exceeded the abnormal level and had clinical significance, and were not suitable for enrollment after evaluation by the investigators;
8. pregnant and lactating women; The reluctance of women or men of childbearing potential to use contraception for the entire dosing period; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;
9. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 2 patient groups

ET-26 0.8mg group

Experimental group

Description:

Experimental

Treatment:

Drug: ET-26HCl 0.8mg/kg group

Etomidate group

Active Comparator group

Description:

Active Comparator

Treatment:

Drug: Etomidate Injectable Product 0.3mg/kg group