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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
358
The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.
The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The awakening time from anesthesia
Time frame: The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes)
Incidence of adverse reactions in the mental system
Time frame: Within 60 minutes after the subject wakes up
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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
...and 2 more locations