Cesarean Section, Efficacy, Midazolam, Pre-eclampsia, Safety
Conditions
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.
Interventions
DRUG0 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
DRUG0.01 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)
DRUG0.02 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
DRUG0.03 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
Zhuji People's Hospital of Zhejiang Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl consumption during sedation | Intraoperative period through 24 hours post-surgery | Total fentanyl dosage (μg) required for adequate sedation in each group. |
| 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. |
| Sedation onset time | 0-60 minutes post-dose | Time (minutes) from midazolam administration to achieving target sedation level (Ramsay Sedation Scale ≥4). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event incidence | 0-48 hours post-surgery | Frequency of hypotension, vomiting, bradycardia, and respiratory depression in each group. |
| Neonatal outcomes by Krebs score | 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. |
Countries
China
Outcome results
None listed