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

NCT06203431 | Unknown Phase 3

• 1 other identifier: ET-26-HCl-301
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Induction

Keywords

Elective Surgery, Adults

Outcome Measures

Primary Outcomes (1)

• Success rate of anesthesia induction

  modified observer's assessment of alert≤1 (only one additional dose was allowed) and endotracheal intubation was completed within 7 minutes from the beginning of study drug infusion, and no remedial drugs were used

  within 7minutes after injection

Secondary Outcomes (10)

• Time to loss of consciousness

  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

• The percentage of time between 40≤BIS（Bispectral index）≤60

  During the period from the initial administration to the successful intubation of the tracheal tube,every 1 minute±20 seconds, within 7minutes after injection

• The percentage of subjects with eyelash reflexes disappearing

  within 3 minutes after injection

• time required to achieve eyelash reflex disappearance

  within 3 minutes after injection

• the use of investigational drugs and remedial drugs

  Induction period of anesthesia,within 7minutes after injection

Study Arms (2)

Drug ET-26

EXPERIMENTAL

Drug: ET-26

Drug Etomidate

ACTIVE COMPARATOR

Drug: Etomidate Injectable Emulsion

Interventions

ET-26 DRUG

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 ET-26

Etomidate Injectable Emulsion DRUG

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.

Drug Etomidate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 clinical significance by the investigator;
• 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;
• 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.

You may not qualify if:

• Subjects with contraindications to general anesthesia or previous history of anesthesia accidents, and other systemic medical history that increases the risk of anesthesia;
• Known or suspected family history of malignant hyperthermia;
• 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;
• Difficulty in intubation or ventilation is expected (Modified Mallampati Score of Ⅲ and 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 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;
• The laboratory examination indicators during the screening period meet the following standards:
• \) 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.

Sponsors & Collaborators

• Ahon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Study Officials

• JIN LIU, Medicine Doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WEIYI ZHANG, Medicine Doctor

CONTACT

18980601837; 1370461@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: January 12, 2024
• Study Start: October 11, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

CN (1)