Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section (annie-zoe)
Primary Purpose
Hypotension Symptomatic, Vasoconstriction, Cesarean Section Complications
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
phenylephrine infusion
norepinephrine infusion
placebo infusion
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension Symptomatic
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
Sites / Locations
- Aretaieion University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
phenylephrine infusion
norepinephrine infusion
placebo infusion
Arm Description
fixed-rate phenylephrine infusion
fixed-rate norepinephrine infusion
normal saline infusion
Outcomes
Primary Outcome Measures
incidence of bradycardia
any incidence of maternal bradycardia (heart rate<60/min) will be recorded
incidence of hypotension
any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded
Secondary Outcome Measures
need for vasoconstrictor
any need for vasoconstrictor during the operation will be recorded
type of vasoconstrictor administered
phenylephrine versus ephedrine
number of bolus doses of vasoconstrictor administered
number of interventions to maintain systolic blood pressure within the set limits will be recorded
total dose of vasoconstrictor administered
total dose in mg for ephedrine or μg for phenylephrine administered
incidence of hypertension
any incidence of systolic blood pressure>120% of baseline will be recorded
need for atropine
any need for atropine during the operation because of bradycardia will be recorded
modification or cessation of the infusion
any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded
incidence of nausea/vomiting
any occurence of nausea and/or vomiting during the operation will be recorded
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.
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.
neonatal blood gases
fetal cord blood analysis will be performed immediately post-delivery
glucose in neonatal blood
glucose will be measured in the cord blood gas sample taken immediately post-delivery
adrenaline in neonatal blood
an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
noradrenaline in neonatal blood
an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
Full Information
NCT ID
NCT04404946
First Posted
May 22, 2020
Last Updated
June 13, 2021
Sponsor
Aretaieion University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04404946
Brief Title
Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section
Acronym
annie-zoe
Official Title
Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension Symptomatic, Vasoconstriction, Cesarean Section Complications, Obstetric Anesthesia Problems
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phenylephrine infusion
Arm Type
Active Comparator
Arm Description
fixed-rate phenylephrine infusion
Arm Title
norepinephrine infusion
Arm Type
Active Comparator
Arm Description
fixed-rate norepinephrine infusion
Arm Title
placebo infusion
Arm Type
Placebo Comparator
Arm Description
normal saline infusion
Intervention Type
Other
Intervention Name(s)
phenylephrine infusion
Other Intervention Name(s)
medication used for blood pressure maintenance
Intervention Description
in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated
Intervention Type
Other
Intervention Name(s)
norepinephrine infusion
Other Intervention Name(s)
medication used for blood pressure maintenance
Intervention Description
in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated
Intervention Type
Other
Intervention Name(s)
placebo infusion
Other Intervention Name(s)
medication used for blood pressure maintenance
Intervention Description
in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated
Primary Outcome Measure Information:
Title
incidence of bradycardia
Description
any incidence of maternal bradycardia (heart rate<60/min) will be recorded
Time Frame
intraoperative
Title
incidence of hypotension
Description
any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
need for vasoconstrictor
Description
any need for vasoconstrictor during the operation will be recorded
Time Frame
intraoperative
Title
type of vasoconstrictor administered
Description
phenylephrine versus ephedrine
Time Frame
intraoperative
Title
number of bolus doses of vasoconstrictor administered
Description
number of interventions to maintain systolic blood pressure within the set limits will be recorded
Time Frame
intraoperative
Title
total dose of vasoconstrictor administered
Description
total dose in mg for ephedrine or μg for phenylephrine administered
Time Frame
intraoperative
Title
incidence of hypertension
Description
any incidence of systolic blood pressure>120% of baseline will be recorded
Time Frame
intraoperative
Title
need for atropine
Description
any need for atropine during the operation because of bradycardia will be recorded
Time Frame
intraoperative
Title
modification or cessation of the infusion
Description
any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded
Time Frame
intraoperative
Title
incidence of nausea/vomiting
Description
any occurence of nausea and/or vomiting during the operation will be recorded
Time Frame
intraoperative
Title
Neonatal Apgar score at 1 minutes
Description
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.
Time Frame
1 minute post delivery
Title
Neonatal Apgar score at 5 minutes
Description
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.
Time Frame
5 minutes post delivery
Title
neonatal blood gases
Description
fetal cord blood analysis will be performed immediately post-delivery
Time Frame
1 minute post delivery
Title
glucose in neonatal blood
Description
glucose will be measured in the cord blood gas sample taken immediately post-delivery
Time Frame
1 minute post delivery
Title
adrenaline in neonatal blood
Description
an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
Time Frame
5 minutes post delivery
Title
noradrenaline in neonatal blood
Description
an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
Time Frame
5 minutes post delivery
Other Pre-specified Outcome Measures:
Title
cardiac output
Description
cardiac output via non-invasive device (Nexfin) will be measured intraoperatively
Time Frame
intraoperative
Title
stroke volume
Description
stroke volume via non-invasive device (Nexfin) will be measured intraoperatively
Time Frame
intraoperative
Title
systemic vascular resistance
Description
systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively
Time Frame
intraoperative
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aretaieion University Hospital
City
Athens
ZIP/Postal Code
115 28
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21415724
Citation
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.
Results Reference
background
PubMed Identifier
20173633
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.
Results Reference
background
PubMed Identifier
29090733
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.
Results Reference
background
PubMed Identifier
27101504
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. No abstract available. Erratum In: Anesth Analg. 2016 Aug;123(2):522.
Results Reference
background
PubMed Identifier
25654435
Citation
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.
Results Reference
background
PubMed Identifier
24106360
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.
Results Reference
background
PubMed Identifier
20715726
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. doi: 10.1177/0310057X1003800337.
Results Reference
background
PubMed Identifier
27746565
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. doi: 10.4103/0259-1162.191118.
Results Reference
background
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Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section
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