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

Overview

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.

Interventions

• 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)
• 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)

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 6 centers

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

Identifiers

NCT: NCT06858852 · ET-26-HCl-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗