A Clinical Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy

NCT ID: NCT06858852

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-12-31

Brief Summary

A total of 270 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 2:1 with etomidate as the control group.Neither the investigators nor the subjects were aware of the group assignments. 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. Compared with etomidate, the efficacy and safety of Methoxyethyl Etomidate Hydrochloride for sedation/anesthesia in gastroscopy/colonoscopy were further evaluated.

Conditions

Gastroscopy; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ET-26 0.8mg group

Experimental

Group Type: EXPERIMENTAL

ET-26HCl 0.8mg/kg group

Intervention Type: DRUG

The initial dose was 0.8 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)

Etomidate group

Active Comparator

Group Type: ACTIVE_COMPARATOR

Etomidate Injectable Product 0.3mg/kg group

Intervention Type: DRUG

The initial dose was 0.3 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)

Interventions

ET-26HCl 0.8mg/kg group

The initial dose was 0.8 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)

Intervention Type: DRUG

Etomidate Injectable Product 0.3mg/kg group

The initial dose was 0.3 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. patients undergoing routine gastroscopy/colonoscopy;

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. Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator

6. 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;

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

2. 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;

3. Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);

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

5. 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;

6. 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;

7. During the screening period, the laboratory examination indicators exceeded the abnormal level and had clinical significance, and were not suitable for enrollment after evaluation by the investigators;

8. 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;

9. 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

Jin Liu

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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

Central Contacts

Xiaoran Yang

Role: CONTACT

yangxiaoran@avancpharma.com

13146214840

Other Identifiers

ET-26-HCl-302

Identifier Type: -

Identifier Source: org_study_id