Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

NCT ID: NCT00199784

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Hypotension during cesarean section with spinal anesthesia is common. We compare low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Phenylephrine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy pregnant women for elective cesarean section

Exclusion Criteria

* Shorter than 160 or taller than 180 cm
* Pre-pregnant body mass index (BMI) over 32
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Eldrid Langesæter, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Rikshospitalet-Radiumhospitalet HF

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 18946298 (View on PubMed)

Other Identifiers

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EudraCT2004-004902-26/S-05049

Identifier Type: -

Identifier Source: secondary_id

Elangesectio2005-1

Identifier Type: -

Identifier Source: org_study_id

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