The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
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
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
Total ephedrine dose
Time frame: intraoperative
Incidence of hypotension
Hypotension: Systolic blood pressure \<80% of baseline
Time frame: intraoperative
Incidence of severe hypotension
Severe hypotension: Systolic blood pressure \<70% of baseline
Time frame: intraoperative
Time to the first ephedrine dose
Time frame: intraoperative
Heart rate
Time frame: intraoperative
Inferior vena cava largest and smallest diameters
Time frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Inferior vena cava collapsibility index
Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter
Time frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Incidence of nausea and/or vomiting
Time frame: intraoperative
Neonatal Apgar score
Time frame: At 1 and 5 minutes after delivery
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Fentanyl 15 µg will be administered in the subarachnoid space
Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
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 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.