2.2.3 Continuous administration
There were 3 dose open groups for continuous administration, with 6
cases in each group, and the time of continuous administration was 24
hours. After the administration, the subjects were discharged after 2
days of hospitalization, and the trial ended after the 28th day. In each
dose group, the dose of intravenous bolus (bolus 30 seconds or more) was
0.4 mg/kg, and the increasing range of maintenance dose was 0.15, 0.30
and 0.45 mg/kg/h. One subject in each group was first enrolled, and the
remaining subjects were then enrolled after observing that there was no
safety problem at least 48 hours after the end of the administration. It
was confirmed that there was no safety problem after the last subject in
the previous dose group had completed the observation to at least the
7th day, then the subjects were entered for the next dose group.
Supervising and guiding the process of drug clinical trials was
performed by establishing a data and safety monitoring committee. The
continuous administration process was shown in Figure 2.