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.
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;
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;
Parallel
ET-26HCl 0.8mg/kg group
DrugThe 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)
Etomidate Injectable Product 0.3mg/kg group
DrugThe 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)
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.
Sedation/anesthesia success rate
Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug
Duration of successful sedation/anesthesia
The time from the first administration of the experimental drug to the MOAA/S score ≤1
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
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
