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

Mansoura University

Status: Completed

Conditions: Cesarean Section; Anesthesia, Spinal

Treatments: Procedure: Spinal Anesthesia; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: 500 mL Crystalloid Coload; Drug: Intravenous Ephedrine; Drug: Intrathecal Fentanyl; Drug: 500 mL Colloid Preload; Procedure: Cesarean Delivery; Drug: 1000 mL Crystalloid Coload; Drug: Intrathecal Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02961842

R/16.09.64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists physical status II parturients
• Full term, singleton pregnancy
• Elective cesarean delivery under spinal anesthesia

Exclusion criteria

• Age <19 or > 40 years
• Height <150 cm
• Weight <60 kg
• Body mass index ≥40 kg/m2
• Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
• Chronic or pregnancy-induced hypertension
• Hemoglobin <10 gm/dL.
• Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
• Polyhydramnios or known fetal abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Combination

Experimental group

Description:

500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.

Treatment:

Drug: 500 mL Crystalloid Coload

Drug: Intrathecal Fentanyl

Radiation: Ultrasound Assessment of the Inferior Vena Cava

Drug: 500 mL Colloid Preload

Procedure: Spinal Anesthesia

Procedure: Cesarean Delivery

Drug: Intravenous Ephedrine

Drug: Intrathecal Bupivacaine

Coload

Active Comparator group

Description:

1000 mL crystalloid coload. 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 will be administered.

Treatment:

Drug: Intrathecal Fentanyl

Radiation: Ultrasound Assessment of the Inferior Vena Cava

Procedure: Spinal Anesthesia

Procedure: Cesarean Delivery

Drug: 1000 mL Crystalloid Coload

Drug: Intravenous Ephedrine

Drug: Intrathecal Bupivacaine