Clinical trial NCT06858852: A Clinical Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gastroscopy
Colonoscopy
Lead sponsor: Ahon Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Success rate of gastroscopy/colonoscopy
timeFrame: Within approximately 1 hour after injection
Secondary outcomes:
measure: Sedation/anesthesia success rate
timeFrame: Within approximately 1 minute of the end of the injection
measure: Duration of successful sedation/anesthesia
timeFrame: within approximately 1minute after injection
measure: Duration from successful insertion to full consciousness
timeFrame: after approximately 30 minutes of the completion of the last injection
measure: Duration from completion of experimental drug administration to full recovery
timeFrame: Within approximately 50 minutes of the completion of the last injection
measure: The time from the end of treatment to full consciousness
timeFrame: Within approximately 60 minutes of the completion of the first injection
measure: The time from the end of the endoscopic session to discharge from the room
timeFrame: A maximum of 10 minutes after awakening
measure: Rate of use of remedial drugs
timeFrame: 60minutes after injection
measure: Test drug additions
timeFrame: 30minutes after injection
measure: Assessment of orientation
timeFrame: 20 minutes after the end of endoscopic treatment
measure: Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated
timeFrame: 60 minutes after the end of endoscopic treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
state: Sichuan
city: Guangyuan
country: China
facility: Guangyuan First People's Hospital
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Sciences
name: Mengchang Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Jin Liu
role: PRINCIPAL_INVESTIGATOR
References: