NCT02961842

Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anesthesia, Spinal
• Cesarean Section

Interventions

Type	Name	Description
DRUG	500 mL Colloid Preload	6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
PROCEDURE	Spinal Anesthesia	Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
DRUG	Intrathecal Bupivacaine	Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
DRUG	Intrathecal Fentanyl	Fentanyl 15 µg will be administered in the subarachnoid space
DRUG	500 mL Crystalloid Coload	Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
DRUG	1000 mL Crystalloid Coload	Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
PROCEDURE	Cesarean Delivery	Lower segment cesarean section using the Pfannenstiel incision
RADIATION	Ultrasound Assessment of the Inferior Vena Cava	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
DRUG	Intravenous Ephedrine	Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.

Timeline

• Start date: 2016-11-20
• Primary completion: 2017-03-09
• Completion: 2017-03-09
• First posted: 2016-11-11
• Last updated: 2017-03-22

Locations

1 site across 1 country: Egypt