Status:
COMPLETED
Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults
Lead Sponsor:
Tongji Hospital
Conditions:
Hypotension During Surgery
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults. Main...
Detailed Description
The data collected in this study is recorded by the researcher in the eCRF, including: 1. Data to be collected during the screening period and before the operation: the basic characteristics of the p...
Eligibility Criteria
Inclusion
- ASA Ⅰ-Ⅲ grade;
- age 18-65 years old;
- gender is not limited;
- planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septoplasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection for general anesthesia intubation patients;
- operation time No more than 90min.
Exclusion
- \- Emergency surgery;
- abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
- abnormal liver function;
- hypovolemia, shock or coma;
- suffering from mental illness and long-term use of psychotropic drugs;
- cognition Dysfunction;
- those who are allergic to or contraindicated to benzodiazepines and their drug components; pregnant or lactating female patients;
- have a history of drug dependence;
- have used other sedatives in the past week;
- have been a subject within the past 3 months Participated in drug clinical trials
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT04908553
Start Date
July 1 2021
End Date
May 31 2025
Last Update
June 29 2025
Active Locations (1)
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1
TongjiHospital
Wuhan, China