Clinical trial NCT04908553: Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults
Official title: Safety and Dose Exploration of Remimazolam Tosilate for Injection for Induction and Maintenance of General Anesthesia Intubation for Elective Short-term Surgery in Adults: a Multi-center, Randomized, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension During Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.

Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.

Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.

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 patient and demographic data;
2. Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.

Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ-Ⅲ grade;
2. age 18-65 years old;
3. gender is not limited;
4. 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;
5. operation time No more than 90min.

Exclusion Criteria:

- Emergency surgery;

1. abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
2. abnormal liver function;
3. hypovolemia, shock or coma;
4. suffering from mental illness and long-term use of psychotropic drugs;
5. cognition Dysfunction;
6. those who are allergic to or contraindicated to benzodiazepines and their drug components; pregnant or lactating female patients;
7. have a history of drug dependence;
8. have used other sedatives in the past week;
9. have been a subject within the past 3 months Participated in drug clinical trials

Primary outcomes:
measure: Incidence of hypotension during the anesthesia
timeFrame: during the anesthesia procedure
measure: The rate of Successful sedation during the anesthesia
timeFrame: during the anesthesia procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: TongjiHospital
Study officials:
affiliation: Tongji Hospital
name: Ailin Luo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: