annie-zoe: Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- incidence of bradycardia [intraoperative]
any incidence of maternal bradycardia (heart rate<60/min) will be recorded
- incidence of hypotension [intraoperative]
any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded
Secondary Outcome Measures
- need for vasoconstrictor [intraoperative]
any need for vasoconstrictor during the operation will be recorded
- type of vasoconstrictor administered [intraoperative]
phenylephrine versus ephedrine
- number of bolus doses of vasoconstrictor administered [intraoperative]
number of interventions to maintain systolic blood pressure within the set limits will be recorded
- total dose of vasoconstrictor administered [intraoperative]
total dose in mg for ephedrine or μg for phenylephrine administered
- incidence of hypertension [intraoperative]
any incidence of systolic blood pressure>120% of baseline 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 minutes [1 minute post delivery]
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.
- Neonatal Apgar score at 5 minutes [5 minutes post delivery]
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.
- neonatal blood gases [1 minute post delivery]
fetal cord blood analysis will be performed immediately post-delivery
- glucose in neonatal blood [1 minute post delivery]
glucose will be measured in the cord blood gas sample taken immediately post-delivery
- adrenaline in neonatal blood [5 minutes post delivery]
an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
- noradrenaline in neonatal blood [5 minutes post delivery]
an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
Other Outcome Measures
- cardiac output [intraoperative]
cardiac output via non-invasive device (Nexfin) will be measured intraoperatively
- stroke volume [intraoperative]
stroke volume via non-invasive device (Nexfin) will be measured intraoperatively
- systemic vascular resistance [intraoperative]
systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aretaieion University Hospital | Athens | Greece | 115 28 |
Sponsors and Collaborators
- Aretaieion University Hospital
Investigators
- Principal Investigator: Kassiani Theodoraki, PhD, DESA, Aretaieion University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 196/25-02-2020