Spinal Anesthesia Induced Hypotension During Cesarean Section

Milton S. Hershey Medical Center82 enrolled

Overview

The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypotension

Interventions

Colloid administrationOTHER

The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

Crystalloid administrationOTHER

The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

phenylephrine infusionDRUG

A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I and II * Elective cesarean section * Weight 50-120 kg, Height 150-180 cm * Normal singleton pregnancy * Beyond 36 weeks gestation * No known fetal abnormalities * Ages 18-35 Exclusion Criteria: * Contraindications to spinal anesthesia * Multiple gestation, placenta previa, accreta * Pregnancy induced hypertension or preeclampsia * Diabetes mellitus, cardiovascular diseases * Coagulopathy * Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction * Baseline HR \<65 * Failed spinal anesthesia/inadequate sensory block for surgery * History of abnormal bleeding * History of adverse reactions to hydroxyethylstarch

Locations (1)

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of Maternal Hypotension

Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Secondary Outcomes

Dosage of Phenylephrine Used

Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Incidence of Maternal Bradycardia

Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Fetal Cord Blood pH

Time frame: delivery of the baby

APGAR Scores

The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).

Time frame: Apgar scores were assessed at 1 amd 5 min after delivery of the baby

Incidence of Maternal Nausea and Vomiting

Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Data from ClinicalTrials.gov

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