Patients undergoing elective general anesthesia surgery
Conditions
Interventions
Step 2 Group profofol:propofol
Step 2 Group Rimazolen:Rimazolen
Phase I Remimazolam 0.2 mg/kg Group:Remimazolam 0.2 mg/kg
Phase I Remimazolam 0.3 mg/kg Group:Remimazolam 0.3 mg/kg
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Before conducting the experiment, it is necessary to thoroughly understand the nature, significance, potential benefits, potential inconveniences, and risks of the experiment. Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete this trial, with at least one subject's legal guardian signing informed consent (subjects aged >= 8 years need to obtain informed consent signed by the subject); 2. Subjects with fertility (such as females who have already had menarche or males who have nocturnal emissions) must agree to abstain from sexual activity (avoiding heterosexual intercourse) for one week from signing the ICF until the last administration of the research drug; 3. Children who plan to undergo elective general anesthesia surgery (tracheal intubation or placement of laryngeal mask mechanical ventilation) are expected to receive anesthesia for a period of 30 minutes to 2 hours, from the start of anesthesia induction to the cessation of anesthesia maintenance; 4. 3 <= Age<18 years old, gender not limited; 5. ASA Level I or Level II; 6. Meets weight standards;
Exclusion criteria
Exclusion criteria: 1. Children undergoing elective heart, lung, extracranial, and liver surgeries; 2. For those who plan to use anesthesia methods other than total intravenous anesthesia from entering the operating room until the end of the surgery, such as inhalation anesthesia, epidural anesthesia, subarachnoid anesthesia, etc; 3. The following medical history or evidence has been collected that increases the risk of sedation/anesthesia and has been determined by the researcher to be unsuitable for participation: children who have undergone general anesthesia within the first 14 days of randomization; Children with known congenital heart disease and cardiovascular disease (bradycardia requiring treatment, hypotension requiring treatment, etc.); Combining mental illness and cognitive impairment, history of epilepsy, etc; 4. Subjects with a history of combined asthma or assessed by researchers to be at risk of mask ventilation difficulties or intubation difficulties; 5. Abnormal liver function, ALT and/or AST>1.5 × ULN; Children with total bilirubin exceeding the upper limit of normal values; Abnormal renal function, BUN >= 1.5 × ULN and/or blood creatinine>ULN; 6. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody were positive in infectious disease screening during screening period; 7. Blood HCG test positive patients with concomitant medication; 8. Children who are intolerant or allergic to benzodiazepines, propofol, opioids, muscle relaxants, and their drug components; 9. Use any of the following drugs within the first 5 drug half lives (based on the actual drug instructions, if the half life is unknown, wash out at least 48 hours): sedative hypnotic drugs such as benzodiazepines (such as diazepam, fluozepam, oxazepam, chlorpromazine, triazolam, alprazolam, estazolam, midazolam, etc.), barbiturates, carbamazepine, phenytoin, magnesium sulfate (only allowed for topical use), chloral hydrate, anesthetic sedatives (sevoflurane, ketamine, etc.), analgesic drugs (morphine, codeine, etc.), muscle relaxants (rocuronium, acetanilide, etc.) Quku ammonium, etc.); 10. Pediatric populations requiring special care (such as deaf mute children) or supervision by courts/social welfare institutions; 11. Children who may experience withdrawal from alcohol, drugs, or medication during the study period, which may affect the effectiveness and safety evaluation of the experimental drug; 12. Within the first 3 months of randomization, the participant has participated in other clinical trials and/or has previously participated in clinical trials of the investigational drug (receiving the investigational drug); 13. Researchers believe that children with any other factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success Rate of Anesthesia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success Rate of Anesthesia induction;Success rate of Anesthesia maintenance;Opioid dosage during anesthesia;composite endpoint;Postoperative delirium incidence rate (PAED score);Anesthesia recovery time;Anesthesia induction time; | — |
Countries
China
Contacts
Public ContactZhang Mazhong
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed