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

NCT07021521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-06-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Zhuji People's Hospital of Zhejiang Province

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2023-04-03
Completion
2023-04-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021521 on ClinicalTrials.gov