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

NCT06858852 | Not Yet Recruiting Phase 3

• 1 other identifier: ET-26-HCl-302
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Success rate of gastroscopy/colonoscopy

  From the time of bolus administration to the completion of gastroscopy/colonoscopy, the following two conditions were met simultaneously: (1) the number of additional doses within any 15 minutes was ≤5; (2) no use of rescue drugs.

  Within approximately 1 hour after injection

Secondary Outcomes (10)

• Sedation/anesthesia success rate

  Within approximately 1 minute of the end of the injection

• Duration of successful sedation/anesthesia

  within approximately 1minute after injection

• Duration from successful insertion to full consciousness

  after approximately 30 minutes of the completion of the last injection

• Duration from completion of experimental drug administration to full recovery

  Within approximately 50 minutes of the completion of the last injection

• The time from the end of treatment to full consciousness

  Within approximately 60 minutes of the completion of the first injection

Study Arms (2)

ET-26 0.8mg group

EXPERIMENTAL

Experimental

Drug: ET-26HCl 0.8mg/kg group

Etomidate group

ACTIVE COMPARATOR

Active Comparator

Drug: Etomidate Injectable Product 0.3mg/kg group

Interventions

ET-26HCl 0.8mg/kg group 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)

ET-26 0.8mg group

Etomidate Injectable Product 0.3mg/kg group 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)

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;
• 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;
• Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator
• 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;
• 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 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 (modified Markov score level III, level IV);
• 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;
• 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;
• 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 (6)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

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

Chengdu, Sichuan, 610072, 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

• Jin Liu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoran Yang

CONTACT

13146214840; yangxiaoran@avancpharma.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: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

CN (6)