NCT04406051

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

May 24, 2020

Last Update Submit

June 13, 2021

Conditions

HypotensionObstetric Anesthesia ProblemsCesarean Section ComplicationsHypotensiveVasoconstriction

Outcome Measures

Primary Outcomes (1)

  • incidence of hypotension

    any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded

    intraoperative

Secondary Outcomes (12)

  • need for vasoconstrictor

    intraoperative

  • type of vasoconstrictor administered

    intraoperative

  • total dose of vasoconstrictor administered

    intraoperative

  • incidence of hypertension

    intraoperative

  • incidence of bradycardia

    intraoperative

  • +7 more secondary outcomes

Study Arms (2)

norepinephrine infusion and colloid preloading (NOR-COL)

ACTIVE COMPARATOR

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)

Procedure: norepinephrine infusion and colloid preloading (NOR-COL)

norepinephrine infusion and crystalloid co-loading (NOR-CRYS)

ACTIVE COMPARATOR

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)

Procedure: norepinephrine infusion and crystalloid co-loading (NOR-CRYST)

Interventions

norepinephrine infusion and colloid preloading (NOR-COL)PROCEDURE

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

norepinephrine infusion and colloid preloading (NOR-COL)
norepinephrine infusion and crystalloid co-loading (NOR-CRYST)PROCEDURE

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

norepinephrine infusion and crystalloid co-loading (NOR-CRYS)

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult parturients, American Society of Anesthesiologists (ASA) I-II,
  • singleton gestation\>37 weeks
  • elective cesarean section

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aretaieion University Hospital

Athens, 115 28, Greece

Location

Alexandra General Hospital of Athens

Athens, 11528, Greece

Location

Related Publications (7)

  • Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.

    PMID: 23076903BACKGROUND

  • 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.

    PMID: 20455872BACKGROUND

  • 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.

    PMID: 20173633BACKGROUND

  • 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.

    PMID: 29090733BACKGROUND

  • 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.

    PMID: 19859776BACKGROUND

  • 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.

    PMID: 21948275BACKGROUND

  • 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.

    PMID: 23379937BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kassiani Theodoraki, PhD, DESA

    Aretaieion University Hospital

    PRINCIPAL INVESTIGATOR

  • Emmanouil Stamatakis, PhD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Sofia Hadzilia, MD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Dimitrios Valsamidis, MD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Konstantina Kalopita, MD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

May 24, 2020

First Posted

May 28, 2020

Study Start

May 26, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)