NCT03842046

Brief Summary

The aim of this double-blind randomized study will be to compare a fixed-rate prophylactic noradrenaline infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

February 13, 2019

Last Update Submit

May 21, 2020

Conditions

Hypotension SymptomaticObstetric Anesthesia ProblemsCesarean Section ComplicationsVasoconstriction

Keywords

hypotensionphenylephrinenoradrenalinecardiac outputfetalmaternal hemodynamicscesarean section

Outcome Measures

Primary Outcomes (1)

  • incidence of bradycardia

    any incidence of heart rate\<60/min will be recorded

    intraoperative

Secondary Outcomes (11)

  • need for vasoconstrictor

    intraoperative

  • type of vasoconstrictor administered

    intraoperative

  • number of bolus doses of vasoconstrictor administered

    intraoperative

  • total dose of vasoconstrictor administered

    intraoperative

  • incidence of hypotension

    intraoperative

  • +6 more secondary outcomes

Study Arms (2)

phenylephrine infusion

ACTIVE COMPARATOR

phenylephrine infusion (30 mL/h corresponding to 50 μg/min)

Procedure: phenylephrine infusion

norepinephrine infusion

ACTIVE COMPARATOR

norepinephrine infusion (30 mL/h corresponding to 4 μg/min)

Procedure: norepinephrine infusion

Interventions

phenylephrine infusionPROCEDURE

In parturients allocated to the phenylephrine group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established

phenylephrine infusion
norepinephrine infusionPROCEDURE

In parturients allocated to the norepinephrine group group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established

norepinephrine infusion

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
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 (15)

  • 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

  • Maayan-Metzger A, Schushan-Eisen I, Todris L, Etchin A, Kuint J. Maternal hypotension during elective cesarean section and short-term neonatal outcome. Am J Obstet Gynecol. 2010 Jan;202(1):56.e1-5. doi: 10.1016/j.ajog.2009.07.012. Epub 2009 Aug 28.

    PMID: 19716536BACKGROUND

  • 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

  • Laudenbach V, Mercier FJ, Roze JC, Larroque B, Ancel PY, Kaminski M, Breart G, Diemunsch P, Subtil D, Lejus C, Fresson J, Arnaud C, Rachet B, Burguet A, Cambonie G; Epipage Study Group. Anaesthesia mode for caesarean section and mortality in very preterm infants: an epidemiologic study in the EPIPAGE cohort. Int J Obstet Anesth. 2009 Apr;18(2):142-9. doi: 10.1016/j.ijoa.2008.11.005. Epub 2009 Feb 4.

    PMID: 19195873BACKGROUND

  • Ngan Kee WD, Khaw KS, Ng FF, Lee BB. Prophylactic phenylephrine infusion for preventing hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2004 Mar;98(3):815-21, table of contents. doi: 10.1213/01.ane.0000099782.78002.30.

    PMID: 14980943BACKGROUND

  • Ngan Kee WD, Khaw KS, Ng FF. Comparison of phenylephrine infusion regimens for maintaining maternal blood pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 2004 Apr;92(4):469-74. doi: 10.1093/bja/aeh088. Epub 2004 Feb 20.

    PMID: 14977792BACKGROUND

  • Siddik-Sayyid SM, Taha SK, Kanazi GE, Aouad MT. A randomized controlled trial of variable rate phenylephrine infusion with rescue phenylephrine boluses versus rescue boluses alone on physician interventions during spinal anesthesia for elective cesarean delivery. Anesth Analg. 2014 Mar;118(3):611-8. doi: 10.1213/01.ane.0000437731.60260.ce.

    PMID: 24299932BACKGROUND

  • Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.

    PMID: 11916798BACKGROUND

  • Ngan Kee WD, Khaw KS, Lau TK, Ng FF, Chui K, Ng KL. Randomised double-blinded comparison of phenylephrine vs ephedrine for maintaining blood pressure during spinal anaesthesia for non-elective Caesarean section*. Anaesthesia. 2008 Dec;63(12):1319-26. doi: 10.1111/j.1365-2044.2008.05635.x.

    PMID: 19032300BACKGROUND

  • Cooper DW, Carpenter M, Mowbray P, Desira WR, Ryall DM, Kokri MS. Fetal and maternal effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2002 Dec;97(6):1582-90. doi: 10.1097/00000542-200212000-00034.

    PMID: 12459688BACKGROUND

  • Stewart A, Fernando R, McDonald S, Hignett R, Jones T, Columb M. The dose-dependent effects of phenylephrine for elective cesarean delivery under spinal anesthesia. Anesth Analg. 2010 Nov;111(5):1230-7. doi: 10.1213/ANE.0b013e3181f2eae1. Epub 2010 Sep 14.

    PMID: 20841418BACKGROUND

  • Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

    PMID: 25635593BACKGROUND

  • Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.

    PMID: 27720613BACKGROUND

  • 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.

    PMID: 25654435BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kassiani Theodoraki, PhD

    Aretaieion University Hospital

    PRINCIPAL INVESTIGATOR

  • Emmanouil Stamatakis, PhD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Dimitrios Valsamidis, PhD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Sofia Chatzilia, PhD

    Alexandra General Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 15, 2019

Study Start

February 16, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

May 26, 2020

Record last verified: 2020-05

Locations

GR(2)