Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.
- Conditions
- Obstetric Anesthesia ProblemsCesarean Section ComplicationsHypotensiveVasoconstrictionHypotension
- Interventions
- Procedure: norepinephrine infusion and crystalloid co-loading (NOR-CRYST)Procedure: norepinephrine infusion and colloid preloading (NOR-COL)
- Registration Number
- NCT04406051
- Lead Sponsor
- Aretaieion University Hospital
- Brief Summary
This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during 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. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.
The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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 and crystalloid co-loading (NOR-CRYS) norepinephrine infusion and crystalloid co-loading (NOR-CRYST) in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg) norepinephrine infusion and colloid preloading (NOR-COL) norepinephrine infusion and colloid preloading (NOR-COL) in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)
- Primary Outcome Measures
Name Time Method 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 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
incidence of bradycardia intraoperative any incidence of maternal bradycardia (heart rate\<60/min) 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
incidence of nausea/vomiting intraoperative any occurence of nausea and/or vomiting during the operation will be recorded
Neonatal Apgar score at 1 min 1 min post delivery Neonatal Apgar score will be recorded at 1 min 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.
Neonatal Apgar score at 5 min 5 min post delivery Neonatal Apgar score will be recorded at 5 min 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.
neonatal blood gases 1 min post delivery fetal cord blood analysis will be performed immediately post-delivery
glucose in neonatal blood 1 min post delivery glucose will be measured in the cord blood gas sample taken immediately post-delivery
incidence of hypertension intraoperative any incidence of systolic blood pressure\>120% of baseline will be recorded
Trial Locations
- Locations (2)
Aretaieion University Hospital
🇬🇷Athens, Greece
Alexandra General Hospital of Athens
🇬🇷Athens, Greece