Table 1 Inclusion/exclusion criteria
Inclusion criteria | Exclusion criteria |
|---|---|
(1) Age, ≤18 and ≤60 years, no gender limit | (1) Need to perform complicated endoscopic techniques for diagnosis and treatment, such as cholangiopancreatography surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa stripping, and oral endoscopic muscle dissection |
(2) Undergoing routine upper gastrointestinal endoscopic diagnosis and treatment | (2) Intend to undergo tracheal intubation |
(3) American Society of Anaeshesiologists (ASA) classification I–II | (3) Judged to have difficulty in managing the respiratory tract (modified Mallampati score is IV) |
(4) 18 kg/m2 < body mass index (BMI) < 28 kg/m2 | (4) Anemia or thrombocytopenia, (hemoglobin < 90 g/L, platelet count <80 × 109/L) |
(5) Time of upper gastrointestinal endoscopy not exceeding 30 min | (5) Diagnosed with lung diseases (asthma, bronchitis, chronic obstructive pulmonary diseases, pulmonary bullae, pulmonary embolism, pulmonary edema, and lung cancer) |
(6) Clearly understand and voluntarily participate in the study; provide signed informed consent | (6) Diagnosed with liver and kidney diseases (aspartate aminotransferase and/or alanine aminotransferase ≥2.5 × upper limits of normal (ULN), total bilirubin ≥1.5 × ULN, and blood creatinine levels greater than the upper normal limit) |
| Â | (7) History of drug and/or alcohol abuse within 2 years before initiating the screening period; average daily alcohol consumption of >2 units of alcohol (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol content or 150 mL grapes liquor) |
|  | (8) Blood pressure not satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure, ≥160 mmHg during the screening period and/or diastolic pressure during the screening period pressure, ≥100 mmHg) |
|  | (9) Sitting systolic blood pressure of ≤90 mmHg during the screening period |
| Â | (10) Pregnant or breastfeeding |
| Â | (11) Allergies or contraindication to benzodiazepines, opioids, propofol, and lidocaine |
| Â | (12) Participated in other drug clinical trials in the past 3 months |
|  | (13) Investigator’s judgment as an unsuitable participant |
| Â | (14) Diagnosed with heart disease (heart failure, angina pectoris, myocardial infarction, and heart rhythm abnormalities) |