Evaluating a new anesthesia drug for elective surgery

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

This study is testing a new anesthesia drug called Methoxyetomidate Hydrochloride to see if it works better and is safer than the current option for adults having elective surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Ahon Pharmaceutical Co., Ltd. (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06203431 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind phase III clinical trial aims to compare the efficacy and safety of Methoxyetomidate Hydrochloride (ET-26) against etomidate for inducing general anesthesia in adults undergoing elective surgery. Participants will be monitored for their response to the anesthesia during procedures lasting at least 30 minutes. The study seeks to provide data that could support the marketing registration of ET-26 as a new anesthetic option.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who require general anesthesia for non-emergency elective surgeries.

Not a fit: Patients with severe comorbidities or those requiring emergency surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective option for anesthesia induction in elective surgeries.

How similar studies have performed: Previous studies have shown promise in the use of similar anesthetic agents, but this specific approach with ET-26 is novel.

Eligibility criteria

Inclusion Criteria:

1. Inpatients requiring tracheal intubation under general anesthesia for Non-emergency, non-cardiothoracic, non-extracranial elective surgery estimated operation duration ≥ 0.5h;
2. Age ≥ 18 and ≤ 70 years old, gender is not limited;
3. ASA（American Society of Anesthesiologists） Class I-II;
4. Body mass index (BMI) 18 \~ 30 kg/m2 (including boundary value);
5. Serum cortisol concentration test is normal or abnormal but judged no clinical significance by the investigator;
6. Vital signs during screening: respiratory rate≥ 10 and ≤ 24 breaths /minute; When breathing air, pulse oxygen saturation (SpO2)≥95%; Systolic blood pressure (SBP) ≥ 90mmHg and ≤160mmHg; diastolic blood pressure (DBP) ≥ 60mmHg and ≤100mmHg; heart rate (ECG results) ≥ 55 and ≤ 100 beats/min;
7. Subjects must understand the procedures and methods of this study and be willing to sign informed consent and strictly abide by this trial protocol to complete the study.

Exclusion Criteria:

1. Subjects with contraindications to general anesthesia or previous history of anesthesia accidents, and other systemic medical history that increases the risk of anesthesia;
2. Known or suspected family history of malignant hyperthermia;
3. Known or suspected of being allergic or contraindicated to the procedural medication prescribed in each component or regimen of the experimental drug, suspected of epilepsy or severe liver and kidney dysfunction;
4. Difficulty in intubation or ventilation is expected (Modified Mallampati Score of Ⅲ and Ⅳ);
5. Presence of any of the following respiratory management risks before/at screening: 1) history of asthma, stridor; 2) Patients with sleep apnea syndrome;
6. Any of the following drugs or treatments were used prior to screening: 1) those who participated in any drug clinical trial within 1 month prior to screening; 2) Have used drugs or treatments that affect cortical function within 3 days before screening; 3) Use of drugs that may affect the QT interval within 2 weeks prior to screening;
7. The laboratory examination indicators during the screening period meet the following standards:

1) AST and /or ALT ≥ 3×ULN; 2)TBIL≥1.5×ULN； 3) Hb≤90 g/L (and no blood transfusion within 14 days); 4)ANC≤1.5×109/L； 5)PLT≤80×109/L； 6) Blood Serum creatinine ≥1.5×ULN; 8. Pregnant and lactating women; the reluctance of fertile women or men to use contraception throughout the trial; subjects (including male subjects) who had pregnancy plans within three months of the trial; 9. Subjects who have any other factors deemed unsuitable for participation in this study by the investigator.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: JIN LIU, Medicine Doctor — West China Hospital
• Study coordinator: WEIYI ZHANG, Medicine Doctor

Conditions Anesthesia Induction; Elective Surgery, Adults