NCT00379691

Brief Summary

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 21, 2007

Status Verified

March 1, 2007

First QC Date

September 21, 2006

Last Update Submit

March 19, 2007

Conditions

HypotensionNausea

Keywords

spinalCesarean sectionhypotensionnauseavomitingphenylephrine

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the minimum dose of phenylephrine which effectively prevents both hypotension and nausea/vomiting between intrathecal injection of the local anesthetic and delivery of the fetus.

Secondary Outcomes (8)

  • Maternal Demographics: Maternal age-weight-height

  • Nausea and Vomiting

  • Time of intrathecal injection, skin incision, uterine incision, and delivery

  • Total dose of phenylephrine

  • Hypertension (> 120 % of baseline)

  • +3 more secondary outcomes

Interventions

phenylephrineDRUG

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
  • Weight 50-100 kg, height 150-180 cm
  • Age over 18 years

You may not qualify if:

  • Patient refusal
  • Allergy or hypersensitivity to phenylephrine
  • Preexisting or pregnancy-induced hypertension
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities
  • History of diabetes, excluding gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

HypotensionNauseaVomiting

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Jose CA Carvalho, MD PhD

    Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 22, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2006

Last Updated

March 21, 2007

Record last verified: 2007-03

Locations

CA(1)