A Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride in Gastroscopy/Colonoscopy

NCT ID: NCT06682546

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2024-12-27

Brief Summary

A total of 78 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 1:1:1 with etomidate as the control group, 26 cases in each group. All subjects were blinded to treatment allocation. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. To preliminarily evaluate the efficacy and safety of ET-26 in gastroscopy/colonoscopy.

Conditions

Gastroscopy; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ET-26 0.6 mg group

0.6mg/kg

Group Type: EXPERIMENTAL

ET-26HCl 0.6mg/kg group

Intervention Type: DRUG

The initial dose is 0.6 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.

ET-26 0.8mg group

0.8mg/kg

Group Type: EXPERIMENTAL

ET-26HCl 0.8mg/kg group

Intervention Type: DRUG

The initial dose is 0.8 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.

Etomidate group

0.3mg/kg

Group Type: ACTIVE_COMPARATOR

Etomidate Injectable Product 0.3mg/kg group

Intervention Type: DRUG

The initial dose is 0.3 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion).Infusion time was 1minute ± 5second.

Interventions

ET-26HCl 0.6mg/kg group

The initial dose is 0.6 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.

Intervention Type: DRUG

ET-26HCl 0.8mg/kg group

The initial dose is 0.8 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.

Intervention Type: DRUG

Etomidate Injectable Product 0.3mg/kg group

The initial dose is 0.3 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion).Infusion time was 1minute ± 5second.

Intervention Type: DRUG

Other Intervention Names

0.6mg group; 0.8mg group; 0.3mg group

Eligibility Criteria

Inclusion Criteria

1. patients undergoing routine gastroscopy/colonoscopy with an expected gastroscopy/colonoscopy procedure time of less than 20 minutes;

2. age ≥ 18 and ≤ 75 years old, regardless of gender;

3. American Society of Anesthesiologists (ASA) grade I-III;

4. Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;

5. Vital signs during screening: respiratory rate ≥10 and ≤24 times/min; Pulse oxygen saturation (SpO2) ≥95% while breathing air; Systolic blood pressure (SBP) ≥90mmHg and ≤160mmHg; Diastolic blood pressure (DBP) ≥60mmHg and ≤100mmHg; Heart rate (ECG) ≥55 and ≤100 beats/min;

6. Serum cortisol concentration was normal or abnormal but not clinically significant according to the investigator's judgment;

7. Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the trial protocol to complete the study.

Exclusion Criteria

1. patients requiring complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.) or undergoing tracheal intubation;

2. patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;

3. patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;

4. predicted difficulty in intubation or ventilation (e.g., modified Mallampti score Ⅲ-Ⅳ, congenital microglossia, mandibular hypoplasia, etc.);

5. having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;

6. QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;

7. use of any of the following drugs or treatments before screening:1) enrolled in a clinical trial of any drug within 1 month before screening; 2) use of medications or treatments that affect cortical function within 3 days before screening; 3) Use of medications that may affect QT interval within 2 weeks before screening;

8. Laboratory tests during the screening period meet the following standards:1)AST and ALT ≥ 3×ULN;2)TBIL≥1.5×ULN;3)hemoglobin ≤90 g/L (and no blood transfusion within 14 days); 4)ANC≤1.5×109/L;5)platelet count ≤80×109/L;6)serum creatinine ≥1.5×ULN;

9. pregnant and lactating women; The reluctance of women or men of childbearing potential to use contraception for the entire dosing period; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;

10. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahon Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mengchang Yang

Role: PRINCIPAL_INVESTIGATOR

Sichuan Academy of Medical Sciences

Locations

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Guangyuan First People's Hospital

Guangyuan, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Countries

China

Other Identifiers

ET-26-HCl-202

Identifier Type: -

Identifier Source: org_study_id