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This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
This randomized, controlled, double blind study will be conducted on women with preeclampsia with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Immediately, after spinal anesthesia administration, patients will receive either 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded at 1 and 5 minutes post-delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination | Experimental | 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered. |
|
| Crystalloid | Active Comparator | 250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Anesthesia | Procedure | Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total urine output at 2 hours post-spinal | 2 hours after intrathecal injection |
| Measure | Description | Time Frame |
|---|---|---|
| Urine output at 1 hour post-spinal | 1 hour after intrathecal injection | |
| Incidence of oliguria | Total urine output at 2 hours post-spinal <60 mL | 2 hours after intrathecal injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Tawfik, MD | Mansoura University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Mansoura University Hospitals | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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| Intrathecal Bupivacaine | Drug | Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space |
|
| Intrathecal Fentanyl | Drug | Fentanyl 15 μg will be administered in the subarachnoid space |
|
| Cesarean Delivery | Procedure | Lower segment cesarean section using the Pfannenstiel incision |
|
| Ultrasound Assessment of the Inferior Vena Cava | Radiation | The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region |
|
| 250 mL Colloid over 5 minutes | Drug | 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection |
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| 250 mL Crystalloid over 5 minutes | Drug | Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection |
|
| 500 mL Crystalloid over 55 minutes | Drug | Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration |
|
| 250 mL Colloid over 60 minutes | Drug | After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes |
|
| 250 mL Crystalloid over 60 minutes | Drug | After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes |
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| Intravenous Ephedrine | Drug | Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively. |
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| Intravenous Syntocinon | Drug | Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution |
|
| Total ephedrine dose | Intraoperative |
| Pre-delivery ephedrine dose | From intrathecal injection until delivery |
| Number of patients requiring ephedrine | Intraoperative |
| Number of patients requiring ephedrine pre-delivery | From intrathecal injection until delivery |
| Incidence of nausea and/or vomiting | Intraoperative |
| Incidence of bradycardia | Heart rate <50 beats/minute | Intraoperative |
| Maximum and minimum inferior vena cava diameters | Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal |
| Inferior vena cava collapsibility index | Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal |
| Neonatal Apgar score | At 1 and 5 minutes after delivery |
| 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 |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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