124
Participants
Start Date
April 5, 2021
Primary Completion Date
April 3, 2023
Study Completion Date
April 26, 2023
0 mg/kg Midazolam (Control Group)
"* Intravenous administration of volume-matched normal saline (0 mg/kg midazolam equivalent)~* Administered as single bolus prior to epidural anesthesia~* Served as active comparator for dose-response evaluation"
0.01 mg/kg Midazolam Group
"* Intravenous midazolam at 0.01 mg/kg (diluted in normal saline)~* Administered as single bolus over 2 minutes~* Manufacturer: Jiangsu Enhua Pharmaceutical Co., Ltd. (Approval H19990027)"
0.02 mg/kg Midazolam Group
"* Intravenous midazolam at 0.02 mg/kg~* Identical administration protocol as 0.01 mg/kg group~* Primary focus: Intermediate dose efficacy/safety assessment"
0.03 mg/kg Midazolam Group
"* Intravenous midazolam at 0.03 mg/kg (maximum tested dose)~* Special hemodynamic monitoring due to dose-dependent MAP effects~* Primary focus: Optimal dose determination"
Zhuji People's Hospital of Zhejiang Province, Shaoxing
Zhuji People's Hospital of Zhejiang Province
OTHER