Clinical trial NCT04406051: Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.
Official title: Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Obstetric Anesthesia Problems
Cesarean Section Complications
Hypotensive
Vasoconstriction
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
Collaborators: name: Alexandra Hospital, Athens, Greece
First posted: 2020-05-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* pregnancy-induced hypertension
* thrombocytopenia
* coagulation abnormalities
* use of antihypertensive medication during pregnancy
* communication or language barriers
* lack of informed consent
* contraindication for regional anesthesia

Primary outcomes:
measure: incidence of hypotension
timeFrame: intraoperative
Secondary outcomes:
measure: need for vasoconstrictor
timeFrame: intraoperative
measure: type of vasoconstrictor administered
timeFrame: intraoperative
measure: total dose of vasoconstrictor administered
timeFrame: intraoperative
measure: incidence of hypertension
timeFrame: intraoperative
measure: incidence of bradycardia
timeFrame: intraoperative
measure: need for atropine
timeFrame: intraoperative
measure: modification or cessation of the infusion
timeFrame: intraoperative
measure: incidence of nausea/vomiting
timeFrame: intraoperative
measure: Neonatal Apgar score at 1 min
timeFrame: 1 min post delivery
measure: Neonatal Apgar score at 5 min
timeFrame: 5 min post delivery
measure: neonatal blood gases
timeFrame: 1 min post delivery
measure: glucose in neonatal blood
timeFrame: 1 min post delivery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandra General Hospital of Athens
name: Emmanouil Stamatakis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandra General Hospital of Athens
name: Sofia Hadzilia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandra General Hospital of Athens
name: Dimitrios Valsamidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandra General Hospital of Athens
name: Konstantina Kalopita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
citation: Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
citation: 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.
citation: 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.
citation: Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.
citation: Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.
citation: Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4.