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Methoxyethyl Etomidate Hydrochloride for Sedation in Gastroscopy/Colonoscopy
NCT06858852Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Mar 2025
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- Procedural sedation (PS)
01
Overview
Phase 3, randomised, double-blind trial of methoxyethyl etomidate in Procedural sedation (PS) (2 arms), sponsored by Jinzhou Ahon Pharmaceutical Co., Ltd. Primary endpoint: Success rate of gastroscopy/colonoscopy at 1 hour. Planned start Mar 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ET-26 0.8mg group
Methoxyethyl Etomidate Hydrochloride 0.8 mg/kg IV
Etomidate group
Etomidate 0.3 mg/kg IV
03
Who it enrols
Adult patients (18-75 years) with ASA grade I-III undergoing routine gastroscopy/colonoscopy, excluding those with difficult intubation, severe respiratory risks, or QTcF prolongation.
04
Endpoints
Primary
Success rate of gastroscopy/colonoscopy
Secondary
Sedation/anesthesia success rate
Duration of successful sedation/anesthesia
Time from successful insertion to full consciousness
Time from the end of the endoscopic session to discharge from the room
Rate of use of remedial drugs
Anesthesiologists' satisfaction with the recovery state
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