drugset / Trial / NCT07021521

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

NCT07021521

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare four different doses of midazolam (0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg) administered intravenously to women with pre-eclampsia undergoing cesarean section. The study aims to evaluate how these different doses affect: The mother's vital signs (oxygen levels, blood pressure, heart rate) The mother's anxiety levels The baby's condition after birth Any potential side effects Participants will be randomly assigned to one of the four dose groups. Medical staff will monitor both mother and baby for 24 hours after the medication is given.

Timeline

Start
2021-04-05
Primary completion
2023-04-03
Completion
2023-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 0.01 mg/kg Intravenous
Subject Midazolam Small molecule 0.02 mg/kg Intravenous
Subject Midazolam Small molecule 0.03 mg/kg Intravenous

Indications