Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypotension Symptomatic
- Sponsor
- Aretaieion University Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- incidence of bradycardia
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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
Detailed 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.
Investigators
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
incidence of bradycardia
Time Frame: intraoperative
any incidence of maternal bradycardia (heart rate\<60/min) will be recorded
incidence of hypotension
Time Frame: intraoperative
any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
Secondary Outcomes
- neonatal blood gases(1 minute post delivery)
- incidence of hypertension(intraoperative)
- need for atropine(intraoperative)
- modification or cessation of the infusion(intraoperative)
- Neonatal Apgar score at 1 minutes(1 minute post delivery)
- need for vasoconstrictor(intraoperative)
- type of vasoconstrictor administered(intraoperative)
- total dose of vasoconstrictor administered(intraoperative)
- incidence of nausea/vomiting(intraoperative)
- number of bolus doses of vasoconstrictor administered(intraoperative)
- adrenaline in neonatal blood(5 minutes post delivery)
- glucose in neonatal blood(1 minute post delivery)
- noradrenaline in neonatal blood(5 minutes post delivery)
- Neonatal Apgar score at 5 minutes(5 minutes post delivery)