nill
Conditions
Interventions
Group A:a Single Bolus of ciprofol(0.6mg/kg) in 1~3 years old patients
Group B:a Single Bolus of ciprofol(0.6mg/kg) in 3~5 years old patients
Group C:a Single Bolus of ciprofol(0.6mg/kg) in 6~12 years old patients
Sponsors
The 2nd Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. The patient's legal guardian obtains informed consent before any study-related activity begins, and has a full understanding of the purpose and significance of this trial, and is willing to comply with the trial protocol; 2. Age 3~6 years old; 3. American Society of Anesthesiologists (ASA) grade I; 4. Patients receive an elective surgery under general anesthesia for more than 1 hour; 5. No potential difficult airway (modified mallampati grade I ~ II); 6. No previous history of organ diseases, such as liver, kidney, digestive tract, blood, metabolism and other medical history, no history of malignant hyperthermia and other genetic diseases, no history of epilepsy, no contraindications to deep sedation/general anesthesia, no history of clinically significant anesthesia accidents;
Exclusion criteria
Exclusion criteria: 1. Patients with anticipated difficult airway, severe respiratory disease, acute respiratory tract infection, uncontrolled asthma and unexplained dyspnea; 2. Patients need special care or supervision by social welfare institutions; 3. Patients with mental system diseases and cognitive dysfunction, history of epilepsy; 4. Patients with cardiovascular diseases (such as congenital heart disease, bradycardia requiring treatment, hypotension requiring treatment, etc.); 5. Patients with abnormal liver function or abnormal renal function; 6. Patients who have used sedative-hypnotics (including benzodiazepines such as diazepam and barbiturates such as phenobarbital) or other analgesics (such as NASIDs) within 7 days before surgery; 7. Patients who have participated in other clinical trials (received experimental drugs or placebo) within 3 months before surgery; 8. Patients who are allergic to the ingredients or components of drugs such as ciprofol and opioids; 9. Patients with anemia that requires treatment;r 10. Other conditions that are not suitable for this clinical trial as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Main Kinetic Parameters of ciprofol; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time of consciousness loss;Bispectral index, BIS;Blood pressure;Heart rate;SpO2; | — |
Countries
China
Contacts
Public ContactWangning Shangguan
The 2nd Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed