Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section

Cesarean Section Complications Clinical Trial

— annie-zoe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404946
• Other study ID #: 196/25-02-2020
• Status: Completed
• Phase: N/A
• Start date: May 23, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension
• Hypotension Symptomatic
• Obstetric Anesthesia Problems
• Vasoconstriction

Intervention

Other:
• phenylephrine infusion
in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated
• norepinephrine infusion
in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated
• placebo infusion
in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Locations

Country	Name	City	State
Greece	Aretaieion University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (8)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Langesæter 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. Review. — View Citation

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. Erratum in: Anesth Analg. 2016 Aug;123(2):522. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cardiac output	cardiac output via non-invasive device (Nexfin) will be measured intraoperatively	intraoperative
Other	stroke volume	stroke volume via non-invasive device (Nexfin) will be measured intraoperatively	intraoperative
Other	systemic vascular resistance	systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively	intraoperative
Primary	incidence of bradycardia	any incidence of maternal bradycardia (heart rate<60/min) will be recorded	intraoperative
Primary	incidence of hypotension	any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded	intraoperative
Secondary	need for vasoconstrictor	any need for vasoconstrictor during the operation will be recorded	intraoperative
Secondary	type of vasoconstrictor administered	phenylephrine versus ephedrine	intraoperative
Secondary	number of bolus doses of vasoconstrictor administered	number of interventions to maintain systolic blood pressure within the set limits will be recorded	intraoperative
Secondary	total dose of vasoconstrictor administered	total dose in mg for ephedrine or µg for phenylephrine administered	intraoperative
Secondary	incidence of hypertension	any incidence of systolic blood pressure>120% of baseline will be recorded	intraoperative
Secondary	need for atropine	any need for atropine during the operation because of bradycardia will be recorded	intraoperative
Secondary	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
Secondary	incidence of nausea/vomiting	any occurence of nausea and/or vomiting during the operation will be recorded	intraoperative
Secondary	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
Secondary	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
Secondary	neonatal blood gases	fetal cord blood analysis will be performed immediately post-delivery	1 minute post delivery
Secondary	glucose in neonatal blood	glucose will be measured in the cord blood gas sample taken immediately post-delivery	1 minute post delivery
Secondary	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
Secondary	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