Clinical trial NCT07021521: Midazolam Efficacy/Safety in Pre-Eclamptic C-Section Sedation
Official title: Efficacy and Safety of Different Doses of Midazolam for 24-Hour Continuous Sedation in Pre-Eclamptic Women Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midazolam
Pre-eclampsia
Cesarean Section
Efficacy
Safety
Lead sponsor: Zhuji People's Hospital of Zhejiang Province
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)
timeFrame: 24 hours after cesarean section.
Secondary outcomes:
measure: Fentanyl consumption during sedation
timeFrame: Intraoperative period through 24 hours post-surgery
measure: Sedation onset time
timeFrame: 0-60 minutes post-dose
measure: Mechanical ventilation duration
timeFrame: From surgery completion until extubation (up to 24 hours)
measure: Hemodynamic stability (MAP)
timeFrame: 30 minutes post-midazolam administration
Other outcomes:
measure: Neonatal outcomes by Krebs score
timeFrame: 30 minutes post-midazolam administration
measure: Adverse event incidence
timeFrame: 0-48 hours post-surgery
Locations:
city: Shaoxing
country: China
facility: Zhuji People's Hospital of Zhejiang Province
state: Zhejiang
Study officials:
References: