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

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Aretaieion University Hospital
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Updated on 16 February 2024
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Summary

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

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.

Details
Condition Vasoconstriction, Cesarean Section Complications, Hypotension Symptomatic, Obstetric Anesthesia Problems
Age 18years - 48years
Treatment phenylephrine infusion, norepinephrine infusion, placebo infusion
Clinical Study IdentifierNCT04404946
SponsorAretaieion University Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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