None listed
Conditions
Interventions
test group:Isoflurane injection, 10 ml: 1.2 g. Administration method: single intravenous injection
administration time: 60±5 s Dosage: 30 mg/kg
Control group:Propofol medium/long chain fat emulsion injection, 20 ml: 0.2g. Administration method: single intravenous injection
administration time: 60±5 s Dosage: 2 mg/kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following conditions to enter the trial: 1) The subjects voluntarily and signed the informed consent form for this trial; 2) 18 years old = 30min);
Exclusion criteria
Exclusion criteria: Subjects must exclude all of the following conditions before entering the trial: 1) Those who are known or suspected of having a history of allergies to various components of the study drug or allergic to narcotic drugs, or allergic to eggs, soybeans and their products; 2) Those with known or suspected genetic history of malignant high fever; 3) Those who plan to undergo transplantation; those who plan to be transferred to ICU after surgery; those who plan to undergo extra-brain, cardiothoracic surgery; 4) The type of planned surgery may affect the collection of BIS index; 5) Those with the following medical history or evidence that increase the risk of sedation/anaesthesia: A. Blood circulation system related: a) Accompanied by infectious heart disease such as myocarditis or endocarditis; sepsis; b) Patients who have implanted heart rate-responsive cardiac pacemakers with bioelectrical impedance sensors; c) Heart failure (NYHA grade III-IV); unstable angina pectoris; myocardial infarction occurred within 6 months before screening; resting ECG heart rate 470ms, female > 480ms; d) People whose blood pressure has not been satisfactorily controlled (SBP >= 160mmHg in the sitting position during the screening period, and/or DBP >= 100 mmHg in the diastolic position); e) SBP = 11.1 mmol/L during the screening period, and/or random blood glucose >= 13.6 mmol/L) E. Digestive system related: Abnormal liver function (ALT or AST >= 2.5 times the upper limit of normal value, TBIL>= 1.5 times the upper limit of normal value); F. Urinary system related: Abnormal renal function (Cr > 1.2 times the upper limit of normal, or dialysis treatment within 28 days before surgery); 6) A history of drug abuse and alcohol abuse within 2 years before the beginning of the screening period; alcohol abuse is defined as regular drinking of more than 14 times a week (1 time = 150 ml wine or 360 ml beer or 45 ml spirits); 7) Pregnant or lactating women or subjects (including men) who have a childbirth plan within 6 months; 8) Those who have participated in any clinical trials as subjects within 3 months before being selected; 9) Use any drugs for sedation, hypnosis, and analgesia (except for external use of Chinese medicine) within 24 hours before randomization; 10) Other situations determined by the researcher to be unsuitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with successful induction of anesthesia (successful induction of anesthesia must also meet: a loss of consciousness of the subject, that is, MOAA/S score = 1 point; b no remedial sedative drugs are used); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of the time that the blood pressure is within the normal range (90mmHg?SBP?140 mmHg) from the start of the study drug to 20 minutes after the start of the drug;The change in blood pressure from the start of the study drug to 20 minutes after the start of the drug;The ratio of time that the bispectral index (BIS) of the study drug is maintained between 40-60 (including the cut-off value) during the period from the start of the drug administration to 20 minutes after the start of the drug administration;The change of bispectral index (BIS) over time from the start of the study drug to 20 minutes after the start of the drug;Intubation response [compare the fluctuation range of systolic blood pressure/heart rate during intubation (maximum systolic blood pressure/heart rate within 5 minutes after intubation-systolic blood pressure/heart rate immediately before laryngoscope insertion)];Intubation success rate: the muscle relaxant rocuronium is successfully intubated within 6 minutes after the administration, and the number of intubations = 3 times is regarded as a successful intubation;The time from the start of the study drug administration to the loss of consciousness;The time from the beginning of the study drug administration to the disappearance of the eyelash reflex;Proportion of subjects using remedial sedatives; | — |
Countries
China
Contacts
Public ContactWensheng Zhang
West China Hospital of Sichuan University
Outcome results
None listed