Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anesthesia Induction
Keywords: Elective Surgery, Adults
Lead sponsor: Ahon Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Success rate of anesthesia induction
timeFrame: within 7minutes after injection
Secondary outcomes:
measure: Time to loss of consciousness
timeFrame: Time from first administration of study drug to MOAA/S（modified observer's assessment of alert）≤1,every 1 minute ±5 seconds, within 3 minutes after injection
measure: The percentage of time between 40≤BIS（Bispectral index）≤60
timeFrame: During the period from the initial administration to the successful intubation of the tracheal tube,every 1 minute±20 seconds, within 7minutes after injection
measure: The percentage of subjects with eyelash reflexes disappearing
timeFrame: within 3 minutes after injection
measure: time required to achieve eyelash reflex disappearance
timeFrame: within 3 minutes after injection
measure: the use of investigational drugs and remedial drugs
timeFrame: Induction period of anesthesia,within 7minutes after injection
measure: Proportion of subjects using remedial sedatives
timeFrame: Induction period of anesthesia,within 7minutes after injection
measure: The time to successfully intubate
timeFrame: within 7minutes after injection
measure: intubation reaction
timeFrame: within 5 minutes after successful intubation
measure: Changes of BIS（Bispectral index） within 30 minutes after endotracheal intubation successfully (such as the time percentage between BIS 40 and BIS 60)
timeFrame: 30 minutes after successful intubation
measure: Anesthesiologists' satisfaction scores on the transition between induction and maintenance of anesthesia.
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: JIN LIU, Medicine Doctor
role: PRINCIPAL_INVESTIGATOR
References: