NCT07021521

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

Efficacy and Safety of Different Doses of Midazolam for 24-Hour Continuous Sedation in Pre-Eclamptic Women Undergoing Cesarean Section

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Zhuji People's Hospital of Zhejiang Province · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aimed to investigate the efficacy and safety of different doses of midazolam for 24-hour continuous sedation in pre-eclamptic women undergoing cesarean section. A total of 124 pre-eclamptic women admitted from April 2021 to April 2023, scheduled for cesarean section at our hospital, were randomly assigned to Group A, Group B, Group C, and Group D, with 31 women in each group. Midazolam was administered intravenously at doses of 0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg, respectively. We compared the oxygen saturation (SPO2), mean arterial pressure (MAP), and heart rate (HR) levels before and 30 minutes after drug administration in all four groups. Visual anxiety scores, fetal Kreb's scores, and sedation efficacy indicators (fentanyl dosage, onset time of sedation, mechanical ventilation time) were assessed in the women at 24 hours before and after the surgery. Adverse reactions were also recorded.

Conditions

• Midazolam
• Pre-eclampsia
• Cesarean Section
• Efficacy
• Safety

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-05
• Primary completion: 2023-04-03
• Completion: 2023-04-26
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

1 site across 1 country: China