Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section
- Conditions
- Hypotension SymptomaticVasoconstrictionObstetric Anesthesia ProblemsCesarean Section Complications
- Interventions
- Other: norepinephrine infusionOther: placebo infusionOther: phenylephrine infusion
- Registration Number
- NCT04404946
- Lead Sponsor
- Aretaieion University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- adult parturients, American Society of Anesthesiologists (ASA) I-II,
- singleton gestation>37 weeks
- elective cesarean section
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description norepinephrine infusion norepinephrine infusion fixed-rate norepinephrine infusion placebo infusion placebo infusion normal saline infusion phenylephrine infusion phenylephrine infusion fixed-rate phenylephrine infusion
- Primary Outcome Measures
Name Time Method incidence of bradycardia intraoperative any incidence of maternal bradycardia (heart rate\<60/min) will be recorded
incidence of hypotension intraoperative any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
- Secondary Outcome Measures
Name Time Method number of bolus doses of vasoconstrictor administered intraoperative number of interventions to maintain systolic blood pressure within the set limits will be recorded
neonatal blood gases 1 minute post delivery fetal cord blood analysis will be performed immediately post-delivery
incidence of hypertension intraoperative any incidence of systolic blood pressure\>120% of baseline will be recorded
need for atropine intraoperative any need for atropine during the operation because of bradycardia will be recorded
modification or cessation of the infusion intraoperative any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded
Neonatal Apgar score at 1 minutes 1 minute post delivery Neonatal Apgar score will be recorded at 1 minutes after delivery. 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. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
need for vasoconstrictor intraoperative any need for vasoconstrictor during the operation will be recorded
type of vasoconstrictor administered intraoperative phenylephrine versus ephedrine
total dose of vasoconstrictor administered intraoperative total dose in mg for ephedrine or μg for phenylephrine administered
noradrenaline in neonatal blood 5 minutes post delivery an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
incidence of nausea/vomiting intraoperative any occurence of nausea and/or vomiting during the operation will be recorded
adrenaline in neonatal blood 5 minutes post delivery an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
glucose in neonatal blood 1 minute post delivery glucose will be measured in the cord blood gas sample taken immediately post-delivery
Neonatal Apgar score at 5 minutes 5 minutes post delivery Neonatal Apgar score will be recorded at 5 minutes after delivery. 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. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
Trial Locations
- Locations (1)
Aretaieion University Hospital
🇬🇷Athens, Greece