Anesthesia InductionPhase 3NCT06203431
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 Phase 3 study testing ET-26 and Etomidate Injectable Emulsion in people with Anesthesia Induction, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia Induction
- What is being tested?
- ET-26 and Etomidate Injectable Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2023to 30 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
About this study
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
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
- Being tested
- ET-26, Etomidate Injectable Emulsion
- Keywords
- Elective Surgery, Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET-26Drug
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.
Etomidate Injectable EmulsionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug ET-26 | Experimental | Not described Receives: Drug: ET-26 |
| Drug Etomidate | Active comparator | Not described Receives: Drug: Etomidate Injectable Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7minutes after injection
Secondary outcomes (10)
Time to loss of consciousness
Measured: 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
Measured: 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
Measured: within 3 minutes after injection
time required to achieve eyelash reflex disappearance
Measured: within 3 minutes after injection
the use of investigational drugs and remedial drugs
Measured: Induction period of anesthesia,within 7minutes after injection
Proportion of subjects using remedial sedatives
Measured: Induction period of anesthesia,within 7minutes after injection
The time to successfully intubate
Measured: within 7minutes after injection
intubation reaction
Whether coughing, body movement reaction
Measured: within 5 minutes after successful intubation
Changes of BIS（Bispectral index） within 30 minutes after endotracheal intubation successfully (such as the time percentage between BIS 40 and BIS 60)
Measured: 30 minutes after successful intubation
Anesthesiologists' satisfaction scores on the transition between induction and maintenance of anesthesia.
The anesthesiologist's satisfaction score for the connection between induction of anesthesia and maintenance of anesthesia, on a scale of 10, 0 being very dissatisfied and 10 being very satisfied.
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start11 Oct 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIN LIU, Medicine Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203431
- Sponsor's protocol ID
- ET-26-HCl-301
- Status last verified
- Jan 2024
- First submitted
- 3 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06203431
- Acronym / sponsor ID
- ET-26-HCl-301
- Conditions
- Anesthesia Induction
- Keywords
- Elective Surgery, Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug ET-26 | Experimental | Drug: ET-26 |
| Drug Etomidate | Active comparator | Drug: Etomidate Injectable Emulsion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ET-26freeze-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 | Drug ET-26 |
| Etomidate Injectable Emulsionlipid 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 | Drug Etomidate |
Primary outcome
Success rate of anesthesia induction
Time frame: within 7minutes after injection
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
10 secondary outcomes
Time to loss of consciousness
Time frame: 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
Time frame: 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
Time frame: within 3 minutes after injection
time required to achieve eyelash reflex disappearance
Time frame: within 3 minutes after injection
the use of investigational drugs and remedial drugs
Time frame: Induction period of anesthesia,within 7minutes after injection
Proportion of subjects using remedial sedatives
Time frame: Induction period of anesthesia,within 7minutes after injection
The time to successfully intubate
Time frame: within 7minutes after injection
intubation reaction
Time frame: within 5 minutes after successful intubation
Changes of BIS（Bispectral index） within 30 minutes after endotracheal intubation successfully (such as the time percentage between BIS 40 and BIS 60)
Time frame: 30 minutes after successful intubation
Anesthesiologists' satisfaction scores on the transition between induction and maintenance of anesthesia.
Time frame: immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIN LIU, Medicine Doctor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ET-26 and Etomidate Injectable Emulsion in people with Anesthesia Induction, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WEIYI ZHANG, Medicine Doctor (18980601837 ext. 610041, 1370461@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of anesthesia induction (time frame: within 7minutes after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.