Anesthesia induction and maintenance
Conditions
Interventions
Test Group 1:Use the experimental drug 12mg/kg in combination with analgesics and muscle relaxants to induce anesthesia, maintaining an initial dose of 10mg/kg/h
Test Group 2:Use the experimental drug 12mg/kg in combination with analgesics and muscle relaxants to induce anesthesia, maintaining the initial dose of 15mg/kg/h
Control group:Use the experimental drug 2mg/kg in combination with analgesics and muscle relaxants to induce anesthesia, maintaining the initial dose of 6mg/kg/h
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Participants must meet all of the following conditions to enter the trial: 1. From 18 years old to 65 years old, regardless of gender; 2. Body mass index (BMI) between 18.5-30 kg/m^2 (BMI=weight (kg)/height^2 (m^2)), with male weight >= 50kg and female weight >= 45kg, including boundary values; 3. Non cardiothoracic and non extracranial surgical subjects who require elective surgery under general anesthesia and tracheal intubation; 4. ASA classification is I-II level; 5. The subjects understand the purpose and steps of this experiment, voluntarily participate in this experiment, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Participants must exclude all of the following conditions before entering the trial: 1. Individuals with contraindications to general anesthesia or a history of anesthesia accidents, or those with a family history of anesthesia accidents (such as malignant hyperthermia, anesthesia drug allergies, etc.); 2. Those who are known or suspected to be allergic or contraindicated to the components of experimental drugs or process drugs; Individuals with allergies (having a history of allergies to two or more substances such as food, medication, dust, etc.); 3. Preoperative use of any medication that may affect the efficacy assessment, and the time interval between the start of administration of such medication and the investigational drug is less than 5 times the half-life; 4. For those who use other anesthesia methods (excluding those specified in the protocol) before awakening from general intravenous anesthesia, such as epidural, subarachnoid anesthesia, nerve block (excluding local incision infiltration), etc; 5. Those planning to undergo extracorporeal circulation, liver resection, or heart, liver, kidney transplantation surgery; 6. Patients with traumatic brain injury, possible intracranial hypertension, cerebral aneurysm, history of cerebrovascular accidents, or central nervous system diseases (such as epilepsy), who are deemed unsuitable for selection by clinical physicians; 7. Suffering from mental system disorders (such as depression, anxiety, schizophrenia, mania, cognitive impairment, etc.), or long-term use of psychotropic drugs (including sedatives, antidepressants, etc.) (continuously used for 30 days or intermittently used for 30 days within 3 months before the administration of experimental drugs); 8. For those who have difficulty in respiratory management or are expected to have difficulty with ventilation and/or intubation: Modified Mahalanobis score of level IV; 9. Abnormal liver function (ALT or AST >= 2.5 times the upper limit of normal value or TBIL >= 1.5 times the upper limit of normal value); Abnormal renal function (Cr>upper limit of normal value, or dialysis treatment within 28 days before surgery); Anemia (Hb = 150mg/dl or >= 1.71mmol/L); 10. Abnormal vital signs (systolic blood pressure140 mmHg, heart rate100 bpm, blood oxygen saturation<95%) or abnormalities in physical examination, 12 lead electrocardiogram, laboratory tests, etc. that have clinical significance and are determined by the researcher to be unsuitable for selection; 11. Pregnant or lactating women or subjects (including males) who have a family plan or are unwilling to use formal contraception within 6 months after the end of the trial drug administration; 12. Participants who have participated in any clinical trial as subjects within 3 months prior to the administration of the investigational drug; Or donate blood or have a total blood loss of = 200mL within 3 months before using the investigational drug; 13. Individuals with a history of drug abuse, drug use, and alcohol abuse within 2 years prior to the administration of the experimental drug. Alcoholism is defined as regularly drinking alcohol more than 14 times a week (1 time=150 mL of wine or 360 mL of beer or 45 mL of spirits); 14. Patients implanted with heart rate responsive pacemakers equipped with bioelectrical impedance sensors; 15. Other situations deemed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of maintaining general anesthesia;The incidence of respiratory tract obstruction (such as tongue prolapse, secretion obstruction, etc.) after extubation;; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects successfully induced by anesthesia;The proportion of subjects successfully induced and maintained anesthesia;Duration of anesthesia maintenance administration;The time from the start of administration of the experimental drug to the loss of consciousness in the subjects;The proportion of time during anesthesia when BIS values are within the range of 40-60;The time from the end of the surgery to the awakening of the subject;The time from the end of the surgery until the subject meets the criteria for exiting the anesthesia recovery room;The dosage of analgesic drugs (remifentanil/sufentanil) used by the subjects during anesthesia;The incidence of hypotension and sinus bradycardia during anesthesia;The incidence of injection pain and elevated blood triglycerides during anesthesia;;The incidence of hypotension before intubation (from subject LOC to immediate intubation), the incidence of hypertension after intubation (from the beginning of intubation to 5 minutes after completion of intubation), and the proportion of subjects using vasoactive drugs from subject LOC to the end of intubation;;Adjust the frequency of experimental drugs during anesthesia maintenance;Quality of anesthesia awakening; | — |
Countries
China
Contacts
Public ContactZhu Tao
West China Hospital of Sichuan University
Outcome results
None listed