About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
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;
Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);
having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
Trial design
Treatments tested in this trial
- ET-26HCl 0.8mg/kg group
- Etomidate Injectable Product 0.3mg/kg group