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

Zhuji People's Hospital of Zhejiang Province

Status: Completed

Conditions: Cesarean Section; Pre-eclampsia; Efficacy; Midazolam; Safety

Treatments: Drug: 0 mg/kg Midazolam (Control Group); Drug: 0.01 mg/kg Midazolam Group; Drug: 0.03 mg/kg Midazolam Group; Drug: 0.02 mg/kg Midazolam Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07021521

No. 2025-0224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women diagnosed with pre-eclampsia [6] requiring emergency or planned cesarean section
• Age 18-40 years
• No history of midazolam or related drug allergies
• Able to comply with study protocol (no communication barriers)
• No history of mental illness or substance abuse
• Provided informed consent (patient or legal representative)

Exclusion criteria

• Concurrent use of drugs interacting with midazolam
• Severe organ dysfunction (heart, liver, or kidneys)
• Participation in other clinical trials potentially affecting results
• Coagulation disorders or hematological conditions
• Inability to adhere to study protocol
• Severe intraoperative complications (e.g., hemorrhage) compromising data reliability
• Additional sedative/analgesic use within 24 hours post-cesarean

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 4 patient groups, including a placebo group

0 mg/kg Midazolam (Control Group)

Placebo Comparator group

Description:

* Received intravenous saline placebo (volume-matched to active doses) * Standard epidural anesthesia with 1.6% lidocaine (15-18 mL to T6 level) * Hemodynamic monitoring per protocol

Treatment:

Drug: 0 mg/kg Midazolam (Control Group)

0.01 mg/kg Midazolam Group

Experimental group

Description:

* Intravenous midazolam at 0.01 mg/kg (Jiangsu Enhua Pharmaceutical Co., Ltd.) * Standard epidural anesthesia as in Arm 1 * Continuous sedation monitoring for 24 hours post-dose

Treatment:

Drug: 0.01 mg/kg Midazolam Group

0.02 mg/kg Midazolam Group

Experimental group

Description:

* Intravenous midazolam at 0.02 mg/kg * Identical anesthesia and monitoring protocols as other arms * Primary focus: Dose-response evaluation for sedation efficacy

Treatment:

Drug: 0.02 mg/kg Midazolam Group

0.03 mg/kg Midazolam Group

Experimental group

Description:

* Intravenous midazolam at 0.03 mg/kg (highest tested dose) * Enhanced monitoring for hemodynamic effects (MAP, HR, SpO₂) * Primary focus: Optimal dose determination balancing efficacy/safety

Treatment:

Drug: 0.03 mg/kg Midazolam Group