Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section (annie-zoe)

Aretaieion University Hospital

Status: Completed

Conditions: Cesarean Section Complications; Hypotension Symptomatic; Obstetric Anesthesia Problems; Vasoconstriction

Treatments: Other: phenylephrine infusion; Other: placebo infusion; Other: norepinephrine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04404946

196/25-02-2020

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

phenylephrine infusion

Active Comparator group

Description:

fixed-rate phenylephrine infusion

Treatment:

Other: phenylephrine infusion

norepinephrine infusion

Active Comparator group

Description:

fixed-rate norepinephrine infusion

Treatment:

Other: norepinephrine infusion

placebo infusion

Placebo Comparator group

Description:

normal saline infusion

Treatment:

Other: placebo infusion