A Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride in Gastroscopy/Colonoscopy
NCT06682546 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2025-05-25
Summary
A total of 78 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 1:1:1 with etomidate as the control group, 26 cases in each group. All subjects were blinded to treatment allocation. 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. To preliminarily evaluate the efficacy and safety of ET-26 in gastroscopy/colonoscopy.
Conditions
- Gastroscopy
- Colonoscopy
Interventions
- DRUG
-
ET-26HCl 0.6mg/kg group
The initial dose is 0.6 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.
- DRUG
-
ET-26HCl 0.8mg/kg group
The initial dose is 0.8 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.
- DRUG
-
Etomidate Injectable Product 0.3mg/kg group
The initial dose is 0.3 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion).Infusion time was 1minute ± 5second.
Sponsors & Collaborators
-
Ahon Pharmaceutical Co., Ltd.
lead OTHER
Principal Investigators
-
Mengchang Yang · Sichuan Academy of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-15
- Primary Completion
- 2024-12-27
- Completion
- 2024-12-27
Countries
- China
Study Locations
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