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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 mg/kg Midazolam (Control Group) | Placebo Comparator |
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| 0.01 mg/kg Midazolam Group | Experimental |
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| 0.02 mg/kg Midazolam Group | Experimental |
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| 0.03 mg/kg Midazolam Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0 mg/kg Midazolam (Control Group) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fentanyl consumption during sedation | Total fentanyl dosage (μg) required for adequate sedation in each group. | Intraoperative period through 24 hours post-surgery |
| Sedation onset time | Time (minutes) from midazolam administration to achieving target sedation level (Ramsay Sedation Scale ≥4). |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal outcomes by Krebs score | 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. | 30 minutes post-midazolam administration |
| Adverse event incidence |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhuji People's Hospital of Zhejiang Province | Shaoxing | Zhejiang | 311800 | China |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 0.01 mg/kg Midazolam Group | Drug |
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| 0.02 mg/kg Midazolam Group | Drug |
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| 0.03 mg/kg Midazolam Group | Drug |
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| 0-60 minutes post-dose |
| Mechanical ventilation duration | Total hours of required mechanical ventilation post-cesarean. | From surgery completion until extubation (up to 24 hours) |
| Hemodynamic stability (MAP) | Mean arterial pressure (mmHg) changes from baseline at 30 minutes post-dose. | 30 minutes post-midazolam administration |
Frequency of hypotension, vomiting, bradycardia, and respiratory depression in each group. |
| 0-48 hours post-surgery |
| D006571 | Heterocyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |