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Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine | Experimental |
| |
| Ephedrine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Anesthesia with Bupivacaine and Fentanyl | Procedure | Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection | From the start of spinal anesthesia until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery | From the start of spinal anesthesia until delivery | |
| Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed M Tawfik, MD | Contact | 0020 1001183400 | m2tawfik@mans.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals | Recruiting | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
IPD will be provided to the Publishing journal if requested
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| Crystalloid Coload 1000 mL | Drug | Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection |
|
| Cesarean Delivery | Procedure | Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization |
|
| Transthoracic Echocardiography | Radiation | Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery |
|
| Intravenous Norepinephrine Bolus | Drug | Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively |
|
| Intravenous Ephedrine Bolus | Drug | Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively |
|
| From the start of spinal anesthesia until delivery |
| Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery | From the start of spinal anesthesia until delivery |
| Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery | From the start of spinal anesthesia until delivery |
| Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery | From the start of spinal anesthesia until delivery |
| Number of patients receiving rescue vasopressor | Systolic blood pressure <90% of baseline value | From the start of spinal anesthesia until delivery |
| Incidence of hypotension | Systolic blood pressure <80% of baseline value | From the start of spinal anesthesia until delivery |
| Incidence of severe hypotension | Systolic blood pressure <70% of baseline value | From the start of spinal anesthesia until delivery |
| Incidence of bradycardia | Heart rate <50 beats/min | From the start of spinal anesthesia until delivery |
| Incidence of nausea and/or vomiting | From the start of spinal anesthesia until delivery |
| Total vasopressor dose | From the start of spinal anesthesia until delivery |
| Neonatal Apgar score at 1 and 5 minutes after delivery | Scale from 0 to 10. Higher scores mean better outcomes. | 1 and 5 minutes after delivery |
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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