None listed
Conditions
Interventions
experimental group 1:Administration of intravenous 0.20 mg/kg NH600001 emulsion injection
experimental group 2:Administration of intravenous 0.25 mg/kg NH600001 emulsion injection
experimental group 3:Administration of intravenous 0.30 mg/kg NH600001 emulsion injection
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 18 and 75 years (including boundary values) at the time of screening; 2. Those with a body mass index (BMI) within the range of 18-30kg/m2 (including the boundary value) and a body weight of<=100 kg; 3. The American Society of Anesthesiologists (ASA) is classified as I-III; 4. Patients receiving routine gastroscopy diagnosis and treatment, and the expected gastroscopy operation time does not exceed 15 minutes; 5. After the subjects fully understand the purpose, content, process, and potential risks of the experiment, those who voluntarily participate and sign an informed consent form; 6. Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate in completing the experimental process.
Exclusion criteria
Exclusion criteria: 1. Patients who require complex endoscopic diagnosis and treatment techniques (such as pancreaticobiliary cholangiography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic muscle dissection, etc.), or who plan to undergo tracheal intubation; 2. Patients with possible obstruction of gastroduodenal outflow tract accompanied by retention of contents or upper gastrointestinal bleeding; 3. The researcher determines that there are diseases or functional impairments that may affect the clinical trial, including but not limited to chronic or severe diseases of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood and lymphatic system, or conditions or surgical history that may significantly affect drug distribution, metabolism, and excretion Medical history and any other special circumstances related to the effects of the investigational drug; 4. Individuals with central nervous system diseases (Parkinson's disease, Alzheimer's disease, idiopathic tremor, hepatolenticular degeneration, Huntington's dance, epilepsy, etc.), mental system diseases (schizophrenia, mania, anxiety, bipolar disorder, mental disorder, etc.), a history of long-term use of psychotropic drugs (continuous use for 30 days or more, intermittent use for 3 months or more), cognitive impairment, brain injury Individuals with a possible history of intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; 5. Known allergy to etomidate, opioids, propofol, naloxone or other narcotic drugs and their similar drug components, soybeans, peanuts, eggs or egg products, or allergic constitution (allergic to two or more drugs, environment or food), or constitution prone to skin rash, urticaria, or a history of allergic diseases; 6. Screening for individuals with severe infection, trauma, or major surgical procedures within the previous month, or those who have not recovered from surgery, or who have expected surgical plans during the trial period; 7. Individuals with a history of anesthesia accidents, severe adverse reactions to anesthesia, or family history of anesthesia accidents; 8. Individuals who have previously had difficulty in ventilation or are suspected of having difficulty with the airway or estimated difficulty with tracheal intubation (such as the modified Mallampti score III-IV, congenital oroglossia, mandibular dysplasia, etc.); 9. Individuals with past or current airway diseases such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome, etc., who have a history of bronchospasm requiring treatment within the first three months of screening, or who have upper respiratory tract infections within the first week of screening, or who have obvious symptoms such as fever, wheezing, nasal congestion, and cough; 10. Individuals with a history of adrenal cortical insufficiency, adrenal tumors, hereditary disorders of heme biosynthesis, or hereditary acute porphyria; 11. Individuals with abnormal laboratory test results during the screening period and clinical significance, and those determined by the researchers to be unsuitable for participation in the study, including but not limited to: those with alanine aminotransferase (ALT), creatinine (Cr), urea nitrogen (BUN), or urea exceeding the normal upper limit by 1.5 times, those with fasting blood glucose 6.1 mmol/L, or those with blood potassium > 5.3 mmol/L; Individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroscopy Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of sedation /anesthesia ;Duration of successful sedation/anesthesia;Duration of bispectral index (BIS) <= 60;Duration of complete awakening after endoscopy;Duration of safe discharge after endoscopy;Proportion of rescue sedation; | — |
Countries
China
Contacts
Public ContactOuyang Wen
The Third Xiangya Hospital of Central South University
Outcome results
None listed