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

Not Applicable

Completed

• Conditions: Midazolam; Pre-eclampsia; Cesarean Section; Efficacy; Safety
• Interventions: Drug: 0 mg/kg Midazolam (Control Group); Drug: 0.01 mg/kg Midazolam Group; Drug: 0.02 mg/kg Midazolam Group; Drug: 0.03 mg/kg Midazolam Group

• Registration Number: NCT07021521
• Lead Sponsor: Zhuji People's Hospital of Zhejiang Province

Brief 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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-05
• Primary Completion: 2023-04-03
• Study Completion: 2023-04-26
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0 mg/kg Midazolam (Control Group)	0 mg/kg Midazolam (Control Group)	* 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
0.01 mg/kg Midazolam Group	0.01 mg/kg Midazolam Group	* 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
0.02 mg/kg Midazolam Group	0.02 mg/kg Midazolam Group	* Intravenous midazolam at 0.02 mg/kg * Identical anesthesia and monitoring protocols as other arms * Primary focus: Dose-response evaluation for sedation efficacy
0.03 mg/kg Midazolam Group	0.03 mg/kg Midazolam Group	* 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

Primary Outcome Measures

Name	Time	Method
Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)	24 hours after cesarean section.	Comparison of anxiety scores using the Visual Analog Anxiety Rating Scale (VAS-A; range 0-10 cm, where 0 = "no anxiety" and 10 = "worst possible anxiety") at 24 hours post-cesarean section among groups receiving different midazolam doses (0, 0.01, 0.02, or 0.03 mg/kg). Higher scores indicate worse anxiety.

Secondary Outcome Measures

Name	Time	Method
Fentanyl consumption during sedation	Intraoperative period through 24 hours post-surgery	Total fentanyl dosage (μg) required for adequate sedation in each group.
Sedation onset time	0-60 minutes post-dose	Time (minutes) from midazolam administration to achieving target sedation level (Ramsay Sedation Scale ≥4).
Mechanical ventilation duration	From surgery completion until extubation (up to 24 hours)	Total hours of required mechanical ventilation post-cesarean.
Hemodynamic stability (MAP)	30 minutes post-midazolam administration	Mean arterial pressure (mmHg) changes from baseline at 30 minutes post-dose.

Trial Locations

Locations (1)

Zhuji People's Hospital of Zhejiang Province; 🇨🇳 Shaoxing, Zhejiang, China