General Anesthesia
Conditions
Interventions
Experimental drug group:single injection of metoetomidate hydrochloride
Control group:Single injection of saline
Positive drug group:Single injection of etomidate
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 45 years, Healthy adult males and females, with full civil capacity; 2.Body weight >=50 kg, BMI: 19-24 kg/m^2 (with boundary values); 3.Blood pressure should be between 90-140/60-90 mmHg (excluding boundary values); Heart rate should be between 50-100 beats/min; Body temperature (forehead temperature) does not exceed 37.3 ?; Respiration rate should be between 12-20 beats/min. Oxygen saturation (SPO2) should be >=95% when inhaling air; 4.Physical examination, laboratory examination (blood routine, blood biochemistry, urine routine and serum cortisol concentration), 12-lead electrocardiogram, orthographic chest X-ray and other examinations were normal or abnormal but not clinically significant as determined by the investigator, and there was no potentially difficult airway (modified Mallampati score was grade I-II); 5.There was no history of important primary organ diseases, such as liver, kidney, heart or blood metabolism, genetic history of malignant high fever, history of neuropsychiatric diseases, history of epilepsy, history of anesthesia accident with clinical significance, and history of adrenal cortical insufficiency; 6.Be able to understand the procedures and methods of the study, be willing to complete the study strictly in accordance with the clinical trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Clinically significant history of allergy, especially drug allergy, or known allergy to any component of the product; 2.Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis or human immunodeficiency virus antibody (HIVAb); 3.Prior to screening history or evidence of any of the following diseases: (1)A history of cardiovascular diseases, such as hypovolume, history of ischemic heart disease, history of tachycardia or bradycardia requiring medical treatment, family history of Adams-Stokes syndrome, abnormal QTcF interval [calculated by Fridericia correction formula: QTcF=QT/(RR0.33)>=430 ms(male) or >=450 ms(female)], history of arrhythmia, postural hypotension, low arterial pressure; (2)A history of respiratory insufficiency, obstructive pulmonary disease, asthma, or bronchospasm requiring treatment within 3 months prior to screening; (3)A history of gastroesophageal reflux of more than 2 weeks within 3 months before screening; 4.A history of drug abuse within 3 months prior to the screening period; Or positive drug abuse screening (screening period or baseline); 5.Screening patients with severe infection, trauma or major surgical operation in the previous 4 weeks; Or acute illness with clinical significance (as determined by the investigator) within 2 weeks prior to screening, such as gastrointestinal illness or infection (such as respiratory tract or central nervous system infection, etc.); 6.Patients have participated in any drug or medical device clinical trial within 3 months prior to screening, and those who have participated in 3 or more drug clinical trial within 1 year prior to screening; Blood donation or blood loss >=200 ml within 30 days before the test; Plasma donation or plasmapheresis within 7 days before the test; 7.A smoking history of more than one week accumulated within 3 months prior to the screening period; 8.Patients have a cumulative history of alcohol abuse of more than 1 week within 3 months prior to the screening period (defined as regular daily consumption of alcohol exceeding the following standards: 570 ml beer, 200 ml red wine or 60 ml white wine, each containing about 20 g alcohol), or who cannot abstain from alcohol during the test period, or who have positive breath test for alcohol; 9.Use of any prescription drugs, Chinese herbal medicine, over-the-counter drugs or food supplements, such as vitamins and calcium supplements, in addition to birth control pills, acetaminophen, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to screening; Only if the principal investigator (PI) and sponsor agree that the drug used has no effect on the safety of the trial and PK/PD results; 10.Patients who consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup =250mL) for more than 1 week in the preceding 3 months were screened; 11.Women who are pregnant or breast-feeding, or who have unprotected sex within the last 2 weeks of the female subject, or who have positive blood pregnancy test; If the subject (or his/her partner) has a birth plan or sperm/egg donor during the entire study period and within 6 months after the end of the study and is unwilling to use one or more contraceptive methods during the study period and within 6 months after the end of the study; 12.Patients with known tendency to severe bleeding, intolerance to venipuncture or difficulty in venous blood col
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security index;tolerance;pharmacodynamic evaluation;adverse event;serious adverse event;pharmacokinetic assessment; | — |
Countries
China
Contacts
Public ContactDeng Xiaoqian
West China Hospital, Sichuan University
Outcome results
None listed