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

Launched by AHON PHARMACEUTICAL CO., LTD. · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Methoxyethyl Etomidate Hydrochloride to see if it is effective and safe for sedation during procedures like gastroscopy and colonoscopy. These procedures involve examining the stomach and intestines, and sedation helps make patients more comfortable. In the trial, 270 participants will be divided into two groups: one will receive the new medication, while the other will receive a standard medication called etomidate. The goal is to compare how well each medication works in keeping patients relaxed and safe during these procedures.

To participate in this trial, individuals should be between 18 and 75 years old, be scheduled for a routine gastroscopy or colonoscopy, and meet certain health criteria. For example, they should have a normal body weight and stable vital signs. Participants will undergo a screening process to ensure they are suitable for the study and will be monitored closely during and after the procedure. It’s important to note that people with certain medical conditions or who are pregnant may not be eligible to join. Overall, this trial aims to gather more information on how well the new medication works compared to the existing option, contributing to better patient care in the future.

Gender

ALL

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.