[Translation] A multicenter, randomized, double-blind, active-drug parallel-controlled, non-inferiority clinical study of glycopyrrolate and neostigmine injection.
主要目的:评价试验组给药结束后心率与基线心率差值的时间曲线下面积(AUC)是否非劣于对照组;次要目的:1.评价试验组给药结束后心率的实测值与对照组相比是否具有差异;2.评价试验组给药结束后心率与基线比较的变化值与对照组相比是否具有差异;3.评价试验组和对照组给药结束后硫酸阿托品补救治疗使用率和使用剂量是否存在差异;4.评价试验组和对照组用药的安全性。
[Translation] Primary objective: To evaluate whether the area under the time curve (AUC) of the difference between the heart rate and the baseline heart rate after the end of drug administration in the experimental group is non-inferior to that in the control group; Secondary objectives: 1. To evaluate whether the measured heart rate after the end of drug administration in the experimental group is different from that in the control group; 2. To evaluate whether the change in heart rate compared with the baseline after the end of drug administration in the experimental group is different from that in the control group; 3. To evaluate whether there are differences in the use rate and dosage of atropine sulfate rescue treatment after drug administration between the experimental group and the control group; 4. To evaluate the safety of medication in the experimental group and the control group.