Respiratory diseases
Conditions
Interventions
1 to 3 years old:Intravenous infusion of rimazolam toluenesulfonic acid 0.2mg/kg
3 (not included) -6 years old:Intravenous infusion of rimazolam toluenesulfonic acid 0.3mg/kg
rimazolam Group:I.V. rimazolam 0.2mg/kg
propofol group:I.V. propofol 2mg/kg
midazolam group:I.V. midazolam 0.2mg/kg
Sponsors
Jinan Children's Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1) Age 1-6, both sexes; 2) Children undergoing routine bronchoscopy; 3) American Society of Anesthesiologists ASA? or ?; 4) BMI 18-30kg/m2; 5) Informed consent, volunteer to participate in the trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their drug components; 2) Anemia or thrombocytopenia, Hb < 90g/L, PLT < 80×109/L; 3) Abnormal liver function, AST and/or ALT=2.5×ULN, TBIL=1.5×ULN; 4) Abnormal renal function, serum creatinine greater than the upper limit of normal; 5) Patients with severe congenital heart disease; 6) Severe pneumonia with dyspnea and SpO2 < 90% without oxygen inhalation; 7) Suspected asthma, exogenous airway foreign body, tracheobronchial stenosis, pulmonary dysplasia, emphysema, airway space-occupying lesions and hemoptysis; 8) Patients with neuromuscular system diseases or mental diseases; 9) Suspected abuse of narcotic analgesics or sedatives; 10) Those who are predicted to have or have had difficult airway; 11) The expected time of bronchoscopy or treatment is greater than 30 minutes; 12) Subjects deemed unfit to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The depth of sedation;CSI index;Systolic blood pressure;Diastolic blood pressure;Heart rate;Pulse oxygen saturation;Sedation induction time;Sedation time to complete recovery;Adverse reactions;Satisfaction; | — |
Countries
China
Contacts
Public ContactWang Shaochao
Jinan Children's Hospital
Outcome results
None listed