Colonoscopy
Conditions
Interventions
remimazolam tosylate 0.1mg/kg:0.1mg/kg initial dose of remimazolam tosylate
remimazolam tosylate 0.1mg/kg:0.15mg/kg initial dose of remimazolam tosylate
remimazolam tosylate 0.2mg/kg:0.2mg/kg initial dose of remimazolam tosylate
Sponsors
Department of Anesthesiology, the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with 18 <= age <= 65 years old, regardless of gender; 2. Patients receiving routine colonoscopy diagnosis and treatment; 3. Patients with ASA grade I or II; 4. Patients with 18 kg / m2 < BMI < 30 kg / m2; 5. Patients whose colonoscopy operation time is not more than 30 minutes; 6. Clearly understand and voluntarily participate in the study, and the informed consent form shall be signed by the patients themselves.
Exclusion criteria
Exclusion criteria: 1. Patients who need complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic myotomy, etc.); 2. Patients to be intubated; 3. Suspected patients with gastroduodenal outflow tract obstruction and retention of contents were suspected to be upper gastrointestinal bleeding patients. 4. Patients with heart failure; unstable angina pectoris; myocardial infarction within 6 months before screening; resting ECG heart rate = 450 ms, female >= 470 MS; 5. Patients with respiratory tract management difficulties (modified Mahalanobis grade IV); 6. Patients with severe respiratory diseases (obstructive sleep apnea syndrome, mouth opening disorder, neck or jaw movement limitation, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.); 7. Patients with SBP <= 90 mmHg in sitting position during screening period; 8. Pregnant or lactating women; 9. Patients who are allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine, flumazenil and other drugs and their components; 10. Participated in drug clinical trials as a patient in recent 3 months; 11. Patients considered unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the success of the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| the induction time of sedation;time to fully alert;injection pain;hypotension in the duration from initial administration of trial drugs to fully alert;hypotension requiring treatment;respiratory depression in the duration from initial administration of trial drugs to fully alert;hyoxemia in the duration from initial administration of trial drugs to fully alert;Recall of the procedure;bucking,nausea and vomiting during and after the procedure;dizzy and delirium after the procedure;Satisfaction of anesthesiologists, endoscopists and patients; | — |
Countries
China
Contacts
Public ContactChenghao
The First Affiliated Hospital of Suzhou University
Outcome results
None listed