NCT01108874

Brief Summary

The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

Enrollment Period

9 months

First QC Date

April 19, 2010

Last Update Submit

September 30, 2010

Conditions

Hypotension

Keywords

Cesarean sectionHypotensionMetaraminolVasoconstrictor AgentsAdultFemalePregnancyAnesthesia, Obstetrical/adverse effectsAnesthesia,SpinalBlood Pressure/drug effectsNauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.

    Bolus doses of metaraminol will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose response curve from where ED90 will be estimated.

    From spinal induction until delivery (on average 30-60min)

Secondary Outcomes (8)

  • Maternal Demographics (Age, Height, Weight and Gestational Age)

  • Incidence of Nausea and Vomiting

    From spinal induction until delivery (on average 30-60min)

  • Time between skin incision and delivery

  • Time between uterine incision and delivery

  • Total dose of metaraminol

  • +3 more secondary outcomes

Interventions

MetaraminolDRUG

Patients will be given metaraminol every time SBP falls below baseline value.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CS under spinal anesthesia
  • Normal singleton pregnancy beyond 36 weeks gestation
  • ASA physical status I/II
  • Age over 18 years

You may not qualify if:

  • Patient refusal
  • Allergy to metaraminol
  • Preexisting or pregnancy-induced hypertension
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (4)

  • Tanaka M, Balki M, Parkes RK, Carvalho JC. ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. Int J Obstet Anesth. 2009 Apr;18(2):125-30. doi: 10.1016/j.ijoa.2008.09.008. Epub 2009 Jan 21.

    PMID: 19162468BACKGROUND

  • Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.

    PMID: 17585226BACKGROUND

  • Ngan Kee WD, Lau TK, Khaw KS, Lee BB. Comparison of metaraminol and ephedrine infusions for maintaining arterial pressure during spinal anesthesia for elective cesarean section. Anesthesiology. 2001 Aug;95(2):307-13. doi: 10.1097/00000542-200108000-00009.

    PMID: 11506099BACKGROUND

  • Ngan Kee WD, Lee A. Multivariate analysis of factors associated with umbilical arterial pH and standard base excess after Caesarean section under spinal anaesthesia. Anaesthesia. 2003 Feb;58(2):125-30. doi: 10.1046/j.1365-2044.2003.02888.x.

    PMID: 12562407BACKGROUND

MeSH Terms

Conditions

HypotensionNauseaVomiting

Interventions

Metaraminol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Jefferson Clivatti, MD

    Disciplina de Anestesiologia, UNIFESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 22, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 1, 2010

Record last verified: 2010-09

Locations

BR(1)