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Completed

NCT Number: NCT07021521

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

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.

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Key information

Conditions

Midazolam Cesarean Section Efficacy Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Safety Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhuji People's Hospital of Zhejiang Province

Shaoxing, Zhejiang, 311800, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

0.01 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)

0.02 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

0.03 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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Fentanyl consumption during sedation

    Time frame: Intraoperative period through 24 hours post-surgery

    Total fentanyl dosage (μg) required for adequate sedation in each group.

  2. Sedation onset time

    Time frame: 0-60 minutes post-dose

    Time (minutes) from midazolam administration to achieving target sedation level (Ramsay Sedation Scale ≥4).

  3. Mechanical ventilation duration

    Time frame: From surgery completion until extubation (up to 24 hours)

    Total hours of required mechanical ventilation post-cesarean.

  4. Hemodynamic stability (MAP)

    Time frame: 30 minutes post-midazolam administration

    Mean arterial pressure (mmHg) changes from baseline at 30 minutes post-dose.

Other outcomes

  1. Neonatal outcomes by Krebs score

    Time frame: 30 minutes post-midazolam administration

    Krebs score (range 0-12, higher=better) assessing fetal wellbeing at 30 minutes post-drug administration. Components: heart rate, muscle tone, skin color, reflex activity, and respiration.

  2. Adverse event incidence

    Time frame: 0-48 hours post-surgery

    Frequency of hypotension, vomiting, bradycardia, and respiratory depression in each group.

Sponsors and collaborators

Lead sponsor

Zhuji People's Hospital of Zhejiang Province

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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