Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery

Mansoura University140 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Pre-Eclampsia Cesarean Section

Interventions

Spinal AnesthesiaPROCEDURE

Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle

Intrathecal BupivacaineDRUG

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intrathecal FentanylDRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick * Singleton pregnancy * Elective cesarean delivery under spinal anesthesia Exclusion Criteria: * Height \<150 cm * Weight \<60 kg * Body mass index ≥45 kg/m2 * Women presenting in labor * Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection) * Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease * Preoperative administration of intravenous hydralazine or magnesium sulphate * Hemoglobin \<10 gm/dL * International Normalized Ratio \>1.3 * Platelet count \<100,000 /mm3 * Preoperative serum creatinine \>1.1 mg/dL

Locations (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Total urine output at 2 hours post-spinal

Time frame: 2 hours after intrathecal injection

Secondary Outcomes

Urine output at 1 hour post-spinal

Time frame: 1 hour after intrathecal injection

Incidence of oliguria

Total urine output at 2 hours post-spinal \<60 mL

Time frame: 2 hours after intrathecal injection

Total ephedrine dose

Time frame: Intraoperative

Pre-delivery ephedrine dose

Time frame: From intrathecal injection until delivery

Number of patients requiring ephedrine

Time frame: Intraoperative

Number of patients requiring ephedrine pre-delivery

Time frame: From intrathecal injection until delivery

Incidence of nausea and/or vomiting

Time frame: Intraoperative

Incidence of bradycardia

Heart rate \<50 beats/minute

Time frame: Intraoperative

Maximum and minimum inferior vena cava diameters

Time frame: Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal

Inferior vena cava collapsibility index

Data from ClinicalTrials.gov

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