remimazolam besylate
Conditions
Interventions
remimazolam group:general anesthesia
propofol group:general anesthesia
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 and = 93%; SBP >= 90mmHg; DBP >= 55mmHg; 5. 50 beats/min <= heart rate <= 100 beats/min; 6. Able to understand and voluntarily sign the Informed Consent (ICF), willing to comply and expected to complete the test in accordance with the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have contraindications to deep sedation/general anesthesia or have a history of sedation/anesthesia accidents; 2. Those who are allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, lidocaine and other drugs and their drug components; 3. Those who have undergone tracheal intubation and/or mechanical ventilation before bronchoscopy diagnosis and treatment; 4. Patients with the following medical history during the screening period/baseline period: A history of cardiovascular system: B history of respiratory system C history of gastrointestinal tract D history of nervous system E history of psychiatric system; 5. Laboratory examination indicators in the screening period meet one of the following standards: 1) Platelet count = 1.5 x ULN; 4) Activated part Thromboplastin time >= 1.5 x ULN; 5) Alanine aminotransferase and/or aspartate aminotransferase >= 3 x ULN; 6) Total bilirubin >= 1.5 x ULN; 7) Serum creatinine >= 1.5 x ULN; 6. The modified Markov score is III or above; 7. A history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the beginning of the screening period; 8. Women who are pregnant or breastfeeding; 8. Reproductive women or men who are unwilling to use contraception during the entire study period; or subjects (including male subjects) who have pregnancy plans within 3 months after the end of the study; 9. Participants in any clinical trials (including drug or device clinical trials) as subjects within 1 month before being selected; 10. Other situations determined by the researcher to be unsuitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Observer's Assessment of Alertness/Sedation S;Aldrete score;Questionnaire on satisfaction of subjects and anesthesiologists;blood pressure;Heart rate, pulse;breathe;Fully awake time; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital
Outcome results
None listed