NCT04404946

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

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 22, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

May 22, 2020

Last Update Submit

June 13, 2021

Conditions

Hypotension SymptomaticVasoconstrictionCesarean Section ComplicationsObstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (2)

  • incidence of bradycardia

    any incidence of maternal bradycardia (heart rate\<60/min) will be recorded

    intraoperative

  • incidence of hypotension

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

    intraoperative

Secondary Outcomes (14)

  • 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 hypertension

    intraoperative

  • +9 more secondary outcomes

Other Outcomes (3)

  • cardiac output

    intraoperative

  • stroke volume

    intraoperative

  • systemic vascular resistance

    intraoperative

Study Arms (3)

phenylephrine infusion

ACTIVE COMPARATOR

fixed-rate phenylephrine infusion

Other: phenylephrine infusion

norepinephrine infusion

ACTIVE COMPARATOR

fixed-rate norepinephrine infusion

Other: norepinephrine infusion

placebo infusion

PLACEBO COMPARATOR

normal saline infusion

Other: placebo infusion

Interventions

phenylephrine infusionOTHER

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

Also known as: medication used for blood pressure maintenance
phenylephrine infusion
norepinephrine infusionOTHER

in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

Also known as: medication used for blood pressure maintenance
norepinephrine infusion
placebo infusionOTHER

in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Also known as: medication used for blood pressure maintenance
placebo infusion

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 (1)

Aretaieion University Hospital

Athens, 115 28, Greece

Location

Related Publications (8)

  • 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.

    PMID: 21415724BACKGROUND

  • 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

  • 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.

    PMID: 27101504BACKGROUND

  • 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

  • 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.

    PMID: 24106360BACKGROUND

  • 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.

    PMID: 20715726BACKGROUND

  • 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.

    PMID: 27746565BACKGROUND

Study Officials

  • Kassiani Theodoraki, PhD, DESA

    Aretaieion University Hospital

    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
Professor of Anesthesiology

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 28, 2020

Study Start

May 23, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)