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

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.

Conditions

• Anesthesia, Spinal
• Cesarean Section

Interventions

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.

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Principal Investigators

• Mohamed M Tawfik, MD · Mansoura University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-20

Primary Completion

2017-03-09

Completion

2017-03-09

Countries

• Egypt

Study Locations