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

A Multicenter, Randomized, Double-blind, Etomidate Parallel Controlled Phase III Clinical Trial Was Conducted to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonoscopy; Gastroscopy
• Intervention / Treatment: Drug: ET-26HCl 0.8mg/kg group; Drug: Etomidate Injectable Product 0.3mg/kg group

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiaoran Yang; Phone Number: 13146214840; Email: yangxiaoran@avancpharma.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
      • Principal Investigator: Dongxin Wang
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • ShenZhen People's Hospital
      • Principal Investigator: Chaoran Wu
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
      • Principal Investigator: Jin Liu
    • Chengdu, Sichuan, China, 610072
      • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
      • Principal Investigator: Mengchang Yang
    • Guangyuan, Sichuan, China, 628017
      • Guangyuan First People's Hospital
      • Principal Investigator: Peng Li
    • Yibin, Sichuan, China, 644000
      • Yibin Second People's Hospital
      • Principal Investigator: Jinghua Ren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ET-26 0.8mg group; Experimental	Drug: 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)
Active Comparator: Etomidate group; Active Comparator	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation/anesthesia success rate	Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug	Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia	The time from the first administration of the experimental drug to the MOAA/S score ≤1	within approximately 1minute after injection
Duration from successful insertion to full consciousness	the time from successful insertion to full awakening (the first time of three consecutive MOAA/S scores reaching 5 points	after approximately 30 minutes of the completion of the last injection
Duration from completion of experimental drug administration to full recovery	The time between the completion of the last trial drug administration and the subject's full recovery (the first of three consecutive MOAA/S scores of 5	Within approximately 50 minutes of the completion of the last injection
The time from the end of treatment to full consciousness	The time from gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5	Within approximately 60 minutes of the completion of the first injection
The time from the end of the endoscopic session to discharge from the room	The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9	A maximum of 10 minutes after awakening
Rate of use of remedial drugs	Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more	60minutes after injection
Test drug additions	the additional situation and dosage of drugs were summarized	30minutes after injection
Assessment of orientation	Orientation was evaluated when MOAA/S reached 5 points for the first time after the complete withdrawal of gastroscopy/colonoscopy	20 minutes after the end of endoscopic treatment
Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated	The total score is 10, that is, a score of 0 indicates very dissatisfied and a score of 10 indicates very satisfied	60 minutes after the end of endoscopic treatment

Collaborators and Investigators

• Sponsor: Ahon Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Mengchang Yang, Sichuan Academy of Medical Sciences; Principal Investigator: Jin Liu, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Etomidate
• Other Study ID Numbers: ET-26-HCl-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No