NCT01509521

Brief Summary

The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

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

January 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

January 8, 2012

Last Update Submit

August 5, 2012

Conditions

Complications; Cesarean Section

Keywords

Spectroscopy, Near-InfraredFetal heartrateEphedrinePhenylephrine

Outcome Measures

Primary Outcomes (2)

  • Frontal lobe cerebral oxygenation

    Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.

    Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour

  • Foetal heartrate

    From before induction of spinal anaesthesia to 15 min after delivery

    Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour

Secondary Outcomes (3)

  • Mean arterial pressure

    Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour

  • Cardiac output

    Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour

  • Umbilical cord pH and Base excess

    Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.

Study Arms (2)

Ephedrine

ACTIVE COMPARATOR
Drug: Ephedrine

Phenylephrine

ACTIVE COMPARATOR
Drug: Phenylephrine

Interventions

EphedrineDRUG

An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.

Also known as: Efedrin, Ephedrine hydrochloride
Ephedrine
PhenylephrineDRUG

An infusion of maximum 4 mg/hour for maximum 60 minutes.

Also known as: Phenylephrine Hydrochloride, Metaoxedrin
Phenylephrine

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy pregnant women
  • Over 18 years old
  • ASA 1-2
  • Undergoing elective caesarean section
  • Height over 160 cm or under 180 cm

You may not qualify if:

  • Allergic reactions to ephedrine or phenylephrine
  • High blood levels of bilirubin
  • HELPP syndrome
  • Preeclampsia (pregnancy-induced hypertension)
  • Non singleton pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naestved Hospital

Næstved, 4700, Denmark

Location

Related Publications (2)

  • Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.

    PMID: 32619039DERIVED

  • Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014.

    PMID: 24624090DERIVED

MeSH Terms

Interventions

EphedrinePhenylephrine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesEthanolamines

Study Officials

  • Visti Foss

    Naestved Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2012

First Posted

January 13, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

DK(1)