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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phenylephrine infusion | Active Comparator | fixed-rate phenylephrine infusion |
|
| norepinephrine infusion | Active Comparator | fixed-rate norepinephrine infusion |
|
| placebo infusion | Placebo Comparator | normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenylephrine infusion | Other | in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of bradycardia | any incidence of maternal bradycardia (heart rate<60/min) will be recorded | intraoperative |
| incidence of hypotension | any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| need for vasoconstrictor | any need for vasoconstrictor during the operation will be recorded | intraoperative |
| type of vasoconstrictor administered | phenylephrine versus ephedrine |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac output | cardiac output via non-invasive device (Nexfin) will be measured intraoperatively | intraoperative |
| stroke volume | stroke volume via non-invasive device (Nexfin) will be measured intraoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Aretaieion University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieion University Hospital | Athens | 115 28 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21415724 | Background | Langesaeter E, Dyer RA. Maternal haemodynamic changes during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2011 Jun;24(3):242-8. doi: 10.1097/ACO.0b013e32834588c5. | |
| 20173633 | Background | Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6. |
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|
| norepinephrine infusion | Other | in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated |
|
|
| placebo infusion | Other | in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated |
|
|
| intraoperative |
| number of bolus doses of vasoconstrictor administered | number of interventions to maintain systolic blood pressure within the set limits will be recorded | intraoperative |
| total dose of vasoconstrictor administered | total dose in mg for ephedrine or μg for phenylephrine administered | intraoperative |
| incidence of hypertension | any incidence of systolic blood pressure>120% of baseline will be recorded | intraoperative |
| need for atropine | any need for atropine during the operation because of bradycardia will be recorded | intraoperative |
| modification or cessation of the infusion | any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded | intraoperative |
| incidence of nausea/vomiting | any occurence of nausea and/or vomiting during the operation will be recorded | intraoperative |
| Neonatal Apgar score at 1 minutes | 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. | 1 minute post delivery |
| Neonatal Apgar score at 5 minutes | 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. | 5 minutes post delivery |
| neonatal blood gases | fetal cord blood analysis will be performed immediately post-delivery | 1 minute post delivery |
| glucose in neonatal blood | glucose will be measured in the cord blood gas sample taken immediately post-delivery | 1 minute post delivery |
| adrenaline in neonatal blood | an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements | 5 minutes post delivery |
| noradrenaline in neonatal blood | an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements | 5 minutes post delivery |
| intraoperative |
| systemic vascular resistance | systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively | intraoperative |
| 29090733 | Background | Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available. |
| 27101504 | Background | Mets B. Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice? Anesth Analg. 2016 May;122(5):1707-14. doi: 10.1213/ANE.0000000000001239. No abstract available. |
| 25654435 | Background | Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available. |
| 24106360 | Background | Sen I, Hirachan R, Bhardwaj N, Jain K, Suri V, Kumar P. Colloid cohydration and variable rate phenylephrine infusion effectively prevents postspinal hypotension in elective Cesarean deliveries. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):348-55. doi: 10.4103/0970-9185.117106. |
| 20715726 | Background | Gunusen I, Karaman S, Ertugrul V, Firat V. Effects of fluid preload (crystalloid or colloid) compared with crystalloid co-load plus ephedrine infusion on hypotension and neonatal outcome during spinal anaesthesia for caesarean delivery. Anaesth Intensive Care. 2010 Jul;38(4):647-53. doi: 10.1177/0310057X1003800337. |
| 27746565 | Background | Kulkarni KR, Naik AG, Deshpande SG. Evaluation of antihypotensive techniques for cesarean section under spinal anesthesia: Rapid crystalloid hydration versus intravenous ephedrine. Anesth Essays Res. 2016 Sep-Dec;10(3):637-642. doi: 10.4103/0259-1162.191118. |