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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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)
• Препарат 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)

Первичные конечные точки

• Success rate of gastroscopy/colonoscopy [Срок оценки: Within approximately 1 hour after injection]

Вторичные конечные точки (10)

• Sedation/anesthesia success rate [Срок оценки: Within approximately 1 minute of the end of the injection]
• Duration of successful sedation/anesthesia [Срок оценки: within approximately 1minute after injection]
• Duration from successful insertion to full consciousness [Срок оценки: after approximately 30 minutes of the completion of the last injection]
• Duration from completion of experimental drug administration to full recovery [Срок оценки: Within approximately 50 minutes of the completion of the last injection]
• The time from the end of treatment to full consciousness [Срок оценки: 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 [Срок оценки: A maximum of 10 minutes after awakening]
• Rate of use of remedial drugs [Срок оценки: 60minutes after injection]
• Test drug additions [Срок оценки: 30minutes after injection]
• Assessment of orientation [Срок оценки: 20 minutes after the end of endoscopic treatment]
• Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated [Срок оценки: 60 minutes after the end of endoscopic treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Peking University First Hospital — Пекин
• Shenzhen People's Hospital — Шэньчжэнь
• West China Hospital of Sichuan University — Чэнду
• Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital — Чэнду
• Guangyuan First People's Hospital — Guangyuan
• Yibin Second People's Hospital — Yibin

Идентификаторы

NCT: NCT06858852 · ET-26-HCl-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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