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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.
The data collected in this study is recorded by the researcher in the eCRF, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group | Other | Remimazolam Tosilate for Injection 0.1mg/kg at induction |
|
| medium dose group | Other | Remimazolam Tosilate for Injection 0.15mg/kg at induction |
|
| high dose group | Other | Remimazolam Tosilate for Injection 0.2mg/kg at induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate for Injection 0.1mg/kg | Drug | Remimazolam Tosilate for Injection 0.1mg/kg at induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension during the anesthesia | The systolic blood pressure during the anesthesia is ≤ 90 mmHg, or a reduction of >20% from the baseline period, or the average blood pressure is <65 mmHg | during the anesthesia procedure |
| The rate of Successful sedation during the anesthesia | Successful sedation during the anesthesia is defined as: 1) successful induction of anesthesia without anesthesia remedial measures during the induction period; 2) no recovery during the anesthesia maintenance period, no unexpected physical activity, and no remedial measures during the maintenance period anesthesia. | during the anesthesia procedure |
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Inclusion Criteria:
Exclusion Criteria:
- Emergency surgery;
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| Name | Affiliation | Role |
|---|---|---|
| Ailin Luo, Doctor | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TongjiHospital | Wuhan | China |
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| Remimazolam Tosilate for Injection 0.15mg/kg | Drug | Remimazolam Tosilate for Injection 0.15mg/kg at induction |
|
|
| Remimazolam Tosilate for Injection 0.2mg/kg | Drug | Remimazolam Tosilate for Injection 0.2mg/kg at induction |
|
|
| ID | Term |
|---|---|
| D007267 | Injections |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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