NCT00199784

Brief Summary

The purpose of this study is to determine the effect of low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac output and systemic vascular resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Jun 2005

Typical duration for phase_4 healthy

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

February 1, 2009

First QC Date

September 13, 2005

Last Update Submit

July 3, 2011

Conditions

Healthy

Keywords

HemodynamicHypotensionSpinalAnesthesiaHealthy pregnant women for elective cesarean section

Outcome Measures

Primary Outcomes (3)

  • Differences in cardiac output

  • Blood pressure

  • Systemic vascular resistance

Secondary Outcomes (3)

  • Nausea

  • Fatigue

  • Cardiovascular instability due to overdosing spinal anesthesia for cesarean section (CS)

Interventions

PhenylephrineDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy pregnant women for elective cesarean section

You may not qualify if:

  • Shorter than 160 or taller than 180 cm
  • Pre-pregnant body mass index (BMI) over 32

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF

Oslo, Oslo County, 0027, Norway

Location

Related Publications (1)

  • Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.

    PMID: 18946298RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Eldrid Langesæter, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Study Completion

April 1, 2007

Last Updated

July 6, 2011

Record last verified: 2009-02

Locations

NO(1)