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

NCT07021521 | Completed

• 1 other identifier: No. 2025-0224
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)

  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.

  24 hours after cesarean section.

Secondary Outcomes (4)

• Fentanyl consumption during sedation

  Intraoperative period through 24 hours post-surgery

• Sedation onset time

  0-60 minutes post-dose

• Mechanical ventilation duration

  From surgery completion until extubation (up to 24 hours)

• Hemodynamic stability (MAP)

  30 minutes post-midazolam administration

Other Outcomes (2)

• Neonatal outcomes by Krebs score

  30 minutes post-midazolam administration

• Adverse event incidence

  0-48 hours post-surgery

Study Arms (4)

0 mg/kg Midazolam (Control Group)

PLACEBO COMPARATOR

* 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

Drug: 0 mg/kg Midazolam (Control Group)

0.01 mg/kg Midazolam Group

EXPERIMENTAL

* 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

Drug: 0.01 mg/kg Midazolam Group

0.02 mg/kg Midazolam Group

EXPERIMENTAL

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

Drug: 0.02 mg/kg Midazolam Group

0.03 mg/kg Midazolam Group

EXPERIMENTAL

* 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

Drug: 0.03 mg/kg Midazolam Group

Interventions

0 mg/kg Midazolam (Control Group) DRUG

* 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

0 mg/kg Midazolam (Control Group)

0.01 mg/kg Midazolam Group DRUG

* 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)

0.01 mg/kg Midazolam Group

0.02 mg/kg Midazolam Group DRUG

* Intravenous midazolam at 0.02 mg/kg * Identical administration protocol as 0.01 mg/kg group * Primary focus: Intermediate dose efficacy/safety assessment

0.02 mg/kg Midazolam Group

0.03 mg/kg Midazolam Group DRUG

* Intravenous midazolam at 0.03 mg/kg (maximum tested dose) * Special hemodynamic monitoring due to dose-dependent MAP effects * Primary focus: Optimal dose determination

0.03 mg/kg Midazolam Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhuji People's Hospital of Zhejiang Province: lead

Study Sites (1)

Zhuji People's Hospital of Zhejiang Province

Shaoxing, Zhejiang, 311800, China

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Midazolam; Control Groups

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 15, 2025
• Study Start: April 5, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 26, 2023
• Last Updated: June 15, 2025

Record last verified: 2021-04

Locations

CN (1)