Midazolam Efficacy/Safety in Pre-Eclamptic C-Section Sedation

NACompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

April 5, 2021

Primary Completion Date

April 3, 2023

Study Completion Date

April 26, 2023

Conditions
MidazolamPre-eclampsiaCesarean SectionEfficacySafety
Interventions
DRUG

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"

DRUG

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)"

DRUG

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"

DRUG

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"

Trial Locations (1)

311800

Zhuji People's Hospital of Zhejiang Province, Shaoxing

All Listed Sponsors
lead

Zhuji People's Hospital of Zhejiang Province

OTHER

NCT07021521 - Midazolam Efficacy/Safety in Pre-Eclamptic C-Section Sedation | Biotech Hunter | Biotech Hunter