Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section (annie-zoe)

Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Vasoconstriction; Obstetric Anesthesia Problems; Hypotension Symptomatic
• Intervention / Treatment: Other: phenylephrine infusion; Other: norepinephrine infusion; Other: placebo infusion

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 115 28
    • Aretaieion University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: phenylephrine infusion; fixed-rate phenylephrine infusion	Other: phenylephrine infusion; in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated; Other Names: medication used for blood pressure maintenance
Active Comparator: norepinephrine infusion; fixed-rate norepinephrine infusion	Other: norepinephrine infusion; in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated; Other Names: medication used for blood pressure maintenance
Placebo Comparator: placebo infusion; normal saline infusion	Other: placebo infusion; in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated; Other Names: medication used for blood pressure maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension	any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded	intraoperative
incidence of bradycardia	any incidence of maternal bradycardia (heart rate<60/min) will be recorded	intraoperative

Secondary Outcome Measures

Outcome Measure	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	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
number of bolus doses of vasoconstrictor administered	number of interventions to maintain systolic blood pressure within the set limits 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

Other Outcome Measures

Outcome Measure	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	intraoperative
systemic vascular resistance	systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively	intraoperative

Collaborators and Investigators

• Sponsor: Aretaieion University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Anesth Analg. 2016 Aug;123(2):522.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Norepinephrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 196/25-02-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No