Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. (annie-manos)
Primary Purpose
Hypotension, Obstetric Anesthesia Problems, Cesarean Section Complications
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
norepinephrine infusion and colloid preloading (NOR-COL)
norepinephrine infusion and crystalloid co-loading (NOR-CRYST)
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension
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
- Alexandra General Hospital of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
norepinephrine infusion and colloid preloading (NOR-COL)
norepinephrine infusion and crystalloid co-loading (NOR-CRYS)
Arm Description
in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)
in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)
Outcomes
Primary Outcome Measures
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
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
incidence of bradycardia
any incidence of maternal bradycardia (heart rate<60/min) 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 min
Neonatal Apgar score will be recorded at 1 min 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 min
Neonatal Apgar score will be recorded at 5 min 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
Full Information
NCT ID
NCT04406051
First Posted
May 24, 2020
Last Updated
June 13, 2021
Sponsor
Aretaieion University Hospital
Collaborators
Alexandra Hospital, Athens, Greece
1. Study Identification
Unique Protocol Identification Number
NCT04406051
Brief Title
Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.
Acronym
annie-manos
Official Title
Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital
Collaborators
Alexandra Hospital, Athens, Greece
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Obstetric Anesthesia Problems, Cesarean Section Complications, Hypotensive, Vasoconstriction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
norepinephrine infusion and colloid preloading (NOR-COL)
Arm Type
Active Comparator
Arm Description
in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)
Arm Title
norepinephrine infusion and crystalloid co-loading (NOR-CRYS)
Arm Type
Active Comparator
Arm Description
in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)
Intervention Type
Procedure
Intervention Name(s)
norepinephrine infusion and colloid preloading (NOR-COL)
Intervention Description
in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
norepinephrine infusion and crystalloid co-loading (NOR-CRYST)
Intervention Description
in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia
Primary Outcome Measure Information:
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
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
incidence of bradycardia
Description
any incidence of maternal bradycardia (heart rate<60/min) 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 min
Description
Neonatal Apgar score will be recorded at 1 min 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 min post delivery
Title
Neonatal Apgar score at 5 min
Description
Neonatal Apgar score will be recorded at 5 min 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 min post delivery
Title
neonatal blood gases
Description
fetal cord blood analysis will be performed immediately post-delivery
Time Frame
1 min 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 min post delivery
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
First Name & Middle Initial & Last Name & Degree
Emmanouil Stamatakis, PhD
Organizational Affiliation
Alexandra General Hospital of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sofia Hadzilia, MD
Organizational Affiliation
Alexandra General Hospital of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitrios Valsamidis, MD
Organizational Affiliation
Alexandra General Hospital of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Konstantina Kalopita, MD
Organizational Affiliation
Alexandra General Hospital of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aretaieion University Hospital
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23076903
Citation
Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10:CD004350. doi: 10.1002/14651858.CD004350.pub3.
Results Reference
background
PubMed Identifier
20455872
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.
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
19859776
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.
Results Reference
background
PubMed Identifier
21948275
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.
Results Reference
background
PubMed Identifier
23379937
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.
Results Reference
background
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Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.
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