Last updated: January 2, 2024
Sponsor: Ahon Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Anesthesia
Treatment
Etomidate Injectable Emulsion
ET-26
Clinical Study ID
NCT06203431
ET-26-HCl-301
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Inpatients requiring tracheal intubation under general anesthesia for Non-emergency,non-cardiothoracic, non-extracranial elective surgery estimated operation duration ≥ 0.5h;
- Age ≥ 18 and ≤ 70 years old, gender is not limited;
- ASA(American Society of Anesthesiologists) Class I-II;
- Body mass index (BMI) 18 ~ 30 kg/m2 (including boundary value);
- Serum cortisol concentration test is normal or abnormal but judged no clinicalsignificance by the investigator;
- Vital signs during screening: respiratory rate≥ 10 and ≤ 24 breaths /minute; Whenbreathing 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;
- Subjects must understand the procedures and methods of this study and be willing tosign informed consent and strictly abide by this trial protocol to complete the study.
Exclusion
Exclusion Criteria:
- Subjects with contraindications to general anesthesia or previous history ofanesthesia accidents, and other systemic medical history that increases the risk ofanesthesia;
- Known or suspected family history of malignant hyperthermia;
- Known or suspected of being allergic or contraindicated to the procedural medicationprescribed in each component or regimen of the experimental drug, suspected ofepilepsy or severe liver and kidney dysfunction;
- Difficulty in intubation or ventilation is expected (Modified Mallampati Score of Ⅲand Ⅳ);
- Presence of any of the following respiratory management risks before/at screening: 1)history of asthma, stridor; 2) Patients with sleep apnea syndrome;
- Any of the following drugs or treatments were used prior to screening: 1) those whoparticipated in any drug clinical trial within 1 month prior to screening; 2) Haveused drugs or treatments that affect cortical function within 3 days before screening;
- Use of drugs that may affect the QT interval within 2 weeks prior to screening;
- The laboratory examination indicators during the screening period meet the followingstandards:
- 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. Pregnantand lactating women; the reluctance of fertile women or men to use contraception throughoutthe trial; subjects (including male subjects) who had pregnancy plans within three monthsof the trial; 9. Subjects who have any other factors deemed unsuitable for participation inthis study by the investigator.
Study Design
Total Participants: 270
Treatment Group(s): 2
Primary Treatment: Etomidate Injectable Emulsion
Phase: 3
Study Start date:
October 11, 2023
Estimated Completion Date:
June 30, 2024
Connect with a study center
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaActive - Recruiting
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