None
Conditions
Interventions
Etomidate :Etomidate (0.3 mg/kg)
ET-26:ET-26 0.8mg/kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Non-emergency, non-cardiothoracic, non-extracerebral elective surgery inpatients with expected operation duration = 0.5 h and tracheal intubation under general anesthesia; 2. Age = 18 and = 70 years old, regardless of gender; 3. American Society of Anesthesiologists (ASA) grade I-II; 4. Body mass index (BMI) 18-30 kg/m2 (including boundary value); 5. Serum cortisol concentration was normal or abnormal but not clinically significant according to the investigator's judgment; 6. 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; 7. 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
Exclusion criteria: 1. Patients with contraindications to general anesthesia or previous history of anesthesia accidents, or other systemic medical history that increases the risk of anesthesia; 2. Known or suspected family history of malignant high fever; 3. Known or suspected to be allergic or contraindicated to each component of the investigational drug or the prescribed regimen, suspected to have epilepsy or severe hepatic and renal dysfunction; 4. Predicted difficulty in intubation or ventilation (modified Mahalanobis scale ?, ?); 5. Having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome; 6. Received 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; 7. Laboratory tests during the screening period meet the following standards: 1) AST and ALT = 3×ULN; 2) TBIL=1.5×ULN; 3) Hemoglobin =90 g/L (and no blood transfusion within 14 days); 4) ANC=1.5×109/L; 5) Platelet count =80×109/L; 6) Serum creatinine =1.5×ULN; 8. Pregnant and lactating women; Women or men of childbearing potential were unwilling to use contraception for the duration of the trial; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial; 9. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of successful induction of anesthesia;The change of BIS during the period from the start of administration to the success of tracheal intubation, the percentage of time 40=BIS=60;;The proportion and duration of loss of eyelash reflexes;The use of study drugs and remedies;Duration of successful intubation and intubation reaction;;Changes in BIS within 30 minutes after successful endotracheal intubation (such as the percentage of time between 40 and BIS and 60);The anesthesiologist's satisfaction score on the connection between induction and maintenance of anesthesia;Changes of serum cortisol during the study period;;The incidence and severity of postoperative nausea and vomiting;;The vital signs of the subjects changed from the beginning of induction to 10min after the end of endotracheal intubation;Changes of vital signs from 10min to 30min after successful tracheal intubation;Laboratory examination, physical examination, electrocardiogram; | — |
Countries
China
Contacts
Public ContactJin Liu/Weiyi Zhang
West China Hospital, Sichuan University
Outcome results
None listed