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The objective is to evaluate the efficacy and safety of BT-KTM-I(Esketamine Hydrochloride Injection produced by Chengdu Brilliant Pharmaceutical Co., Ltd.) for general anesthesia, using the Originator drug Ketanest®S(Esketamine Hydrochloride Injection) as a positive control.
This is a multicenter, randomized, double-blind, positive drug parallel controlled clinical trial, planned to include 358 subjects, including 179 in the experimental group and 179 in the control group. The entire study was divided into a screening period, surgery day, and follow-up observation period. The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h. The experiment used vital signs, physical examination, laboratory examination, 12-lead electrocardiogram examination, and adverse events/serious adverse events for safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT-KTM-I | Experimental | Patients received 0.5mg/kg BT-KTM-I during anesthesia induction period. Patients received 0.5mg/kg/h BT-KTM-I during anesthesia maintenance period. |
|
| Ketanest®S | Active Comparator | Patients received 0.5mg/kg Ketanest®S during anesthesia induction period. Patients received 0.5mg/kg/h Ketanest®S during anesthesia maintenance period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-KTM-I | Drug | The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The awakening time from anesthesia | The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions in the mental system | Within 60 minutes after the subject wakes up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen Ouyang, MD | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | China | |||
| The First Affiliated Hospital, Sun Yat-sen University |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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| Ketanest®S | Drug | The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h. |
|
|
| Guangzhou |
| Guangdong |
| China |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| Hunan Provincial Maternal and Child Health Care Hospital | Changsha | Hunan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Second Hospital University of South China | Hengyang | Hunan | China |
| Pidu District People's Hospital, Chengdu | Chengdu | Sichuan | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| West China Second University Hospital, Sichuan University | Chengdu | Sichuan | China |
| The Second People's hospital of Neijiang | Neijiang | Sichuan | China |
| The Second People's Hospital of Yibin | Yibin | Sichuan | China |