Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section

Aretaieion University Hospital120 enrolled

Overview

This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Hypotension Symptomatic Vasoconstriction Cesarean Section Complications Obstetric Anesthesia Problems

Interventions

phenylephrine infusionOTHER

in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated

norepinephrine infusionOTHER

in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

placebo infusionOTHER

in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult parturients, American Society of Anesthesiologists (ASA) I-II, * singleton gestation\>37 weeks * elective cesarean section Exclusion Criteria: * Body Mass Index (BMI) \>40 kg/m2 * Body weight \<50 kg * Body weight\>100 kg * height\<150 cm * height\>180 cm * multiple gestation * fetal abnormality * fetal distress * active labor * cardiac disease * pregnancy-induced hypertension * thrombocytopenia * coagulation abnormalities * use of antihypertensive medication during pregnancy * communication or language barriers * lack of informed consent * contraindication for regional anesthesia

Locations (1)

Aretaieion University Hospital

Athens, Greece

Outcomes

Primary Outcomes

incidence of bradycardia

any incidence of maternal bradycardia (heart rate\<60/min) will be recorded

Time frame: intraoperative

incidence of hypotension

any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded

Time frame: intraoperative

Secondary Outcomes

need for vasoconstrictor

any need for vasoconstrictor during the operation will be recorded

Time frame: intraoperative

type of vasoconstrictor administered

phenylephrine versus ephedrine

Time frame: intraoperative

number of bolus doses of vasoconstrictor administered

number of interventions to maintain systolic blood pressure within the set limits will be recorded

Time frame: intraoperative

total dose of vasoconstrictor administered

total dose in mg for ephedrine or μg for phenylephrine administered

Time frame: intraoperative

incidence of hypertension

any incidence of systolic blood pressure\>120% of baseline will be recorded

Time frame: intraoperative

need for atropine

any need for atropine during the operation because of bradycardia will be recorded

Time frame: intraoperative

Data from ClinicalTrials.gov

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