A Multicenter, Randomized, Double-blind, Etomidate Parallel Controlled Phase III Clinical Trial Was Conducted to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy
Sponsor study identifier
interventional
270
1 country
6
Study Start
March 2025
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Primary Completion
December 2025
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Study Completion
December 2025
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2025
Actual (reported)March 2025
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March 5, 2025
Actual (reported)December 2025
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December 2025
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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
Sedation/anesthesia success rate
Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia
within approximately 1minute after injection
Duration from successful insertion to full consciousness
after approximately 30 minutes of the completion of the last injection
Duration from completion of experimental drug administration to full recovery
Within approximately 50 minutes of the completion of the last injection
The time from the end of treatment to full consciousness
Within approximately 60 minutes of the completion of the first injection
Experimental
Active Comparator
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)
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)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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
Mengchang Yang
Sichuan Academy of Medical Sciences
Jin Liu
West China Hospital
First Submitted
February 28, 2025
First Posted
March 5, 2025
Study Start
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2025
Sedation Techniques for Outpatient Colonoscopy
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Guangyuan First People's Hospital
Guangyuan, Sichuan, 628017, China
Yibin Second People's Hospital
Yibin, Sichuan, 644000, China
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
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Last Updated
March 5, 2025
Record last verified: 2025-02
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