None
Conditions
Interventions
IIa Etomidate Group:Etomidate was given intravenously 0.3 mg/kg
IIa ET-26 in different dose groups:Different doses of ET-26
IIb Etomidate group:Etomidate was given intravenously 0.3 mg/kg
IIb ET-26 group:ET-26 was administered intravenously at 0.8 mg/kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Non-emergency, non-cardiothoracic, non-extracerebral elective surgery in patients with expected operation duration = 0.5 h and tracheal intubation under general anesthesia; 2. Age = 18 and = 65 years old; 3. American Society of Anesthesiologists (ASA) grade I-II; 4. Body mass index (BMI) 18-30 kg/m^2 (including boundary value); 5. Serum cortisol concentration was normal or abnormal but not clinically significant according to the investigator's judgment; 6. 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. Known or suspected family history of malignant hyperthermia or previous anesthetic accident; 2. Known allergy to the investigational drug or known or suspected epilepsy or severe hepatic and renal insufficiency; 3. Difficult intubation or ventilation is expected; 4. Participants who had participated in any drug clinical trial within 1 month before screening; Use of medications or treatments affecting cortical function within 3 days before screening; 5. 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=1.5×10^9/L; 5) platelet count =80×10^9/L; 6) serum creatinine =1.5×ULN; 6. 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; 7. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase IIa : Proportion of subjects with successful induction of anesthesia;Phase IIb: Proportion of subjects successfully induced anesthesia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase IIa :Changes in the state of consciousness (i.e., name response and eyelash reflexes) after ET-26 injection;Phase IIa: Changes in the BIS index;Phase IIa: The total experimental drugs and the use of supplementary and remedial drugs;Phase IIb: The proportion and duration of eyelash reflex loss;Phase IIb: Duration of loss of consciousness (MOAA/S=1);Phase IIb: Changes of BIS during the period from the beginning of administration to successful intubation;Phase IIb: Research drug use and remedial drug use;Phase IIb: Duration of intubation success and intubation reaction;Phase IIb: Length of full wakefulness;Phase IIb: The length of time required to leave the recovery room; | — |
Countries
china
Contacts
Public ContactJin Liu/Weiyi Zhang
West China Hospital, Sichuan University
Outcome results
None listed