The Oxygenation of the Brain During Caesarean Section (OBDUC)

August 5, 2012 updated by: Visti Foss, Naestved Hospital

The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine

The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

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

  • Denmark
      • Naestved, Denmark, 4700
        • Naestved Hospital

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women
  • Over 18 years old
  • ASA 1-2
  • Undergoing elective caesarean section
  • Height over 160 cm or under 180 cm

Exclusion Criteria:

  • Allergic reactions to ephedrine or phenylephrine
  • High blood levels of bilirubin
  • HELPP syndrome
  • Preeclampsia (pregnancy-induced hypertension)
  • Non singleton pregnancies

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ephedrine
Drug: Ephedrine
An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.
Other Names:
  • Efedrin
  • Ephedrine hydrochloride
Active Comparator: Phenylephrine
Drug: Phenylephrine
An infusion of maximum 4 mg/hour for maximum 60 minutes.
Other Names:
  • Phenylephrine Hydrochloride
  • Metaoxedrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frontal lobe cerebral oxygenation
Time Frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.
Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Foetal heartrate
Time Frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
From before induction of spinal anaesthesia to 15 min after delivery
Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure
Time Frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery.
Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Cardiac output
Time Frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
The cardiac output is measures from before induction of spinal anaesthesia to end of surgery.
Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Umbilical cord pH and Base excess
Time Frame: Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.
The umbilical cord blood analysis for evaluation of the newborn's acid-base status is taken immediately after delivery. It is the most objective way of assessing the fetal metabolic condition at birth.
Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.

Collaborators and Investigators

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

Sponsor

Naestved Hospital

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Visti Foss, Naestved Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 8, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 5, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-006103-35
  • SJ-271 (Other Identifier: Sponsor´s protocol code number)

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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