Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

January 9, 2013 updated by: Jana Christine Kuhn, Anestesiavdelingen Baerum Sykehus

Hemodynamic Effect of Prophylactic Phenylephrine Versus Lower Limb Compression in Women During Caesarean Section Under Spinal Anaesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Rud, Akershus, Norway, 1309
        • Bærum sykehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm

Exclusion Criteria:

Any form of disease or anomalities:

Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Neither phenylephrine nor lower limb bandaging
Active Comparator: Phenylephrine
Drug: Phenylephrine
Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min
Active Comparator: Lower limb compression
Device: Lower limb compression
Tight bandaging of lower extremity up to hips with compression bandages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Invasive arterial bloodpressure
Time Frame: Until end of operation, up to roughly 1 hour
Until end of operation, up to roughly 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
pH value from umbilical vessels of the newborn
Time Frame: straight after delivery
straight after delivery
APGAR score of the newborn
Time Frame: 1 + 5 + 10 minutes after delivery
1 + 5 + 10 minutes after delivery
Need for rescue pressor (ephedrine, phenylephrine)
Time Frame: Until end of operation, roughly 1 hour
Until end of operation, roughly 1 hour
Cardiac Output
Time Frame: Until end of operation, roughly 1 hour
Until end of operation, roughly 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anestesiavdelingen Baerum Sykehus

Investigators

  • Principal Investigator: Jana Christine Kuhn, Dr.med., Bærum sykehus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-013025-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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