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Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

NCT01278238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-01-11

No results posted yet for this study

Summary

The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.

The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.

Conditions

  • Caesarean Section

Interventions

DRUG

Phenylephrine

Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

DEVICE

Lower limb compression

Tight bandaging of lower extremity up to hips with compression bandages

OTHER

Placebo

Neither phenylephrine nor lower limb bandaging

Sponsors & Collaborators

  • Anestesiavdelingen Baerum Sykehus

    lead OTHER

Principal Investigators

  • Jana Christine Kuhn, Dr.med. · Bærum sykehus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278238 on ClinicalTrials.gov