NCT06203431

A Trial to Evaluate the Efficacy and Safety of Methoxyetomidate Hydrochloride for Injection (ET-26) for the Induction of General Anesthesia in Elective Surgery Subjects

A Multicenter, Randomized, Double-blind, Etomidate-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of ET-26 for Induction of General Anesthesia in Subjects Undergoing Elective Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, etomidate-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between ET-26 and etomidate in the induction of general anesthesia in subjects undergoing elective surgery, so as to provide a reference for the marketing registration of methoetomidate hydrochloride for injection.

Conditions

• Anesthesia Induction

Interventions

Type	Name	Description
DRUG	ET-26	freeze-dried powder injection，The initial dose is 0.8 mg/kg, with an additional 50% starting dose if needed. single dose, Infusion time was 60s ± 5s.
DRUG	Etomidate Injectable Emulsion	lipid emulsion ，The initial dose is 0.3 mg/kg, with an additional 50% starting dose if needed.single dose, Infusion time was 60s ± 5s.

Timeline

• Start date: 2023-10-11
• Primary completion: 2024-04-30
• Completion: 2024-06-30
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: China