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

NCT06682546 | Completed Phase 2

• 1 other identifier: ET-26-HCl-202
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Success rate of gastroscopy/colonoscopy

  Number of appends ≤5; No alternative medications or other sedatives/anesthetics were used from the beginning of the first dose of the trial product until the completion of gastroscopy/colonoscopy.

  within approximately 15minutes after injection

Secondary Outcomes (12)

• Sedation/anesthesia success rate

  Within approximately 1 minute of the end of the injection

• Duration of successful sedation/anesthesia

  within approximately 1minute after injection

• Insertion duration

  within approximately 7minutes after the first injection

• Success rate of lens insertion

  within approximately 7minutes after the last injection

• Duration from completion of experimental drug administration to full recovery

  Within approximately 30 minutes of the completion of the last injection

Study Arms (3)

ET-26 0.6 mg group

EXPERIMENTAL

0.6mg/kg

Drug: ET-26HCl 0.6mg/kg group

ET-26 0.8mg group

EXPERIMENTAL

0.8mg/kg

Drug: ET-26HCl 0.8mg/kg group

Etomidate group

ACTIVE COMPARATOR

0.3mg/kg

Drug: Etomidate Injectable Product 0.3mg/kg group

Interventions

ET-26HCl 0.6mg/kg group 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.

Also known as: 0.6mg group

ET-26 0.6 mg group

ET-26HCl 0.8mg/kg group 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.

Also known as: 0.8mg group

ET-26 0.8mg group

Etomidate Injectable Product 0.3mg/kg group 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.

Also known as: 0.3mg group

Etomidate group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing routine gastroscopy/colonoscopy with an expected gastroscopy/colonoscopy procedure time of less than 20 minutes;
• age ≥ 18 and ≤ 75 years old, regardless of gender;
• American Society of Anesthesiologists (ASA) grade I-III;
• Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;
• 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;
• Serum cortisol concentration was normal or abnormal but not clinically significant according to the investigator's judgment;
• 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.

You may not qualify if:

• patients requiring complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.) or undergoing tracheal intubation;
• patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
• 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;
• predicted difficulty in intubation or ventilation (e.g., modified Mallampti score Ⅲ-Ⅳ, congenital microglossia, mandibular hypoplasia, etc.);
• having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
• 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;
• 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;
• 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;
• 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;
• Subjects with any other factors considered by the investigator to be ineligible for participation in the trial

Sponsors & Collaborators

• Ahon Pharmaceutical Co., Ltd.: lead

Study Sites (3)

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

Chengdu, Sichuan, China

Location

Guangyuan First People's Hospital

Guangyuan, Sichuan, 628017, China

Location

Yibin Second People's Hospital

Yibin, Sichuan, 644000, China

Location

MeSH Terms

Interventions

ET-26 compound; Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Mengchang Yang

  Sichuan Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 15, 2024
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)