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This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Spinal anesthesia is commonly used during C-sections but can cause a drop in the mother's blood pressure, which may affect both the mother and the baby.
In this study, 46 pregnant women undergoing elective C-sections were randomly given either norepinephrine (4 mcg) or phenylephrine (50 mcg) when their blood pressure dropped. Researchers monitored their heart rate, blood pressure, and any side effects for 30 minutes after anesthesia.
The results showed that both drugs were effective in raising blood pressure. However, norepinephrine kept the heart rate more stable, while phenylephrine caused a noticeable slowing of the heart rate (bradycardia). Both drugs were safe and well tolerated.
This study suggests that norepinephrine may be a better option for managing low blood pressure during spinal anesthesia in C-sections, especially when maintaining heart rate and cardiac output is important.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine Group | Experimental | Participants in this group received intravenous bolus doses of norepinephrine 4 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section. |
|
| Phenylephrine Group | Experimental | Participants in this group received intravenous bolus doses of phenylephrine 50 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine 4mcg | Drug | Norepinephrine 4 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) After Vasopressor Administration | Change in systolic blood pressure measured before vasopressor administration (T0-T1) and two minutes after administration (T2) in response to intravenous bolus of norepinephrine 4 mcg or phenylephrine 50 mcg during spinal anesthesia-induced hypotension in cesarean section patients. | Baseline to 2 minutes post-administration (T0-T2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adam Malik Hospital | Medan | North Sumatra | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2025 | Aug 29, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Phenylephrine 50 mcg | Drug | Phenylephrine 50 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia. |
|
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |