Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery
Condition: Pre-Eclampsia; Cesarean Section
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Interventional

Summary: 
      This study will compare between combination of colloids/crystalloids and crystalloids in
      women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
    

Detailed description: 
      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.
    

Intervention name(s): Spinal Anesthesia; Intrathecal Bupivacaine; Intrathecal Fentanyl; Cesarean Delivery; Ultrasound Assessment of the Inferior Vena Cava; 250 mL Colloid over 5 minutes; 250 mL Crystalloid over 5 minutes; 500 mL Crystalloid over 55 minutes; 250 mL Colloid over 60 minutes; 250 mL Crystalloid over 60 minutes; Intravenous Ephedrine; Intravenous Syntocinon
Intervention type(s): Procedure; Drug; Drug; Procedure; Radiation; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; Fentanyl 15 μg will be administered in the subarachnoid space; Lower segment cesarean section using the Pfannenstiel incision; 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; 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; Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection; Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration; 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; After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes; Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.; Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Intervention MeSH terms: Ephedrine; Fentanyl; Bupivacaine; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment