Intravenous anesthetics
Conditions
Interventions
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 18 to 75 years (including the cutoff value) at screening; 2) Body mass index (BMI) in the range of 18-30 kg/m^2 (including the cut-off value) and body weight = 30 min; 5) Subjects who voluntarily participated and signed informed consent after fully understanding the purpose, content, process and possible risks of the trial; 6) Able to communicate well with the investigators, willing and able to abide by the lifestyle restrictions specified in the protocol, and cooperate to complete the trial process.
Exclusion criteria
Exclusion criteria: 1) patients with contraindications to general anesthesia, previous history of anesthesia accidents, or other systemic diseases that increase the risk of anesthesia; 2) known or suspected family history of malignant hyperthermia, history of anesthesia accident, history of serious adverse reactions to anesthesia, or family history of anesthesia accident; 3) patients with central nervous system diseases (Parkinson's disease, Alzheimer's disease, essential tremor, hepatolenticular degeneration, Huntington's disease, epilepsy, etc.), mental system diseases (schizophrenia, mania, anxiety disorder, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs (continuous use for 30 days or more, Intermittent use for 3 months or more), cognitive impairment, craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, and cerebrovascular accident history; 4) known or suspected allergies to or contraindications to each component of the investigational drug or to the process medication specified in the protocol (including but not limited to etomidate, midazolam, propofol, opioids, rocuronium, naloxone or other narcotic drugs and their similar drug components, soy, peanut, egg or egg products); Or allergic constitution (allergic to two or more drugs, environment or food), or prone to rash, urticaria and other constitutions; 5) patients who had severe infection, trauma, or major surgical operation within 1 month before screening, or did not recover from surgery; 6) patients with previous difficult ventilation or suspected difficult airway or expected difficult tracheal intubation (such as modified Mallampati score III-IV, congenital microglossia, mandibular dysplasia, etc.); 7) previous or current history of bronchial asthma, chronic obstructive pulmonary disease, or sleep apnea If the patients had a history of bronchospasm requiring treatment within 3 months before screening, or had a respiratory infection within 1 week before screening, or had obvious symptoms such as fever, wheezing, nasal obstruction, and cough; 8) a history of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria; 9) alanine aminotransferase (ALT) more than 3 times the upper limit of normal, serum creatinine (Cr) more than 1.5 times the upper limit of normal, blood urea nitrogen (BUN) or urea more than 1.5 times the upper limit of normal, fasting blood glucose 6.1 mmol/L or serum potassium >5.3 mmol/L; Hemoglobin = 450 ms (male) or >= 470 ms (female) at screening and confirmed by re-examination; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study; 11) those with difficulty in blood collection, intolerance to venipuncture, and/or a history of dizzy with blood or needle; 12) pregnant or lactating women at screening; Refuse to use an effective nonpharmacologic contraceptive (e.g., abstinence, an intrauterine device), or have a sperm or egg donor plan throughout the study and for 3 months after the study; 13) had participated in any clinical trial within 1 month before dosing or were in follow-up in another trial; 14) predicted poor adherence or othe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of sedation/anesthesia;Modified Observer's Assessment of Alertness/Sedation Scale;Duration of successful sedation/anesthesia;Duration of BIS reaching 60 or below;BIS minimum value;Duration of successful tracheal intubation and intubation response;The use of experimental drugs and other sedative anesthetics;Anesthesiologists' satisfaction score with induction of anesthesia; | — |
Countries
China
Contacts
Public ContactWen Ouyang/ Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed