The Oxygenation of the Brain During Caesarean Section (OBDUC)

This study has been completed.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Visti Foss, Naestved Hospital
ClinicalTrials.gov Identifier:
NCT01509521
First received: January 8, 2012
Last updated: August 5, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Complications; Cesarean Section
Drug: Ephedrine
Drug: Phenylephrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine

Resource links provided by NLM:


Further study details as provided by Naestved Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.

  • 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 ] [ Designated as safety issue: Yes ]
    From before induction of spinal anaesthesia to 15 min after delivery


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery.

  • 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 ] [ Designated as safety issue: Yes ]
    The cardiac output is measures from before induction of spinal anaesthesia to end of surgery.

  • 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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 24
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509521

Locations
Denmark
Naestved Hospital
Naestved, Denmark, 4700
Sponsors and Collaborators
Naestved Hospital
Rigshospitalet, Denmark
Investigators
Principal Investigator: Visti Foss Naestved Hospital
  More Information

No publications provided

Responsible Party: Visti Foss, Principal Investigator, Naestved Hospital
ClinicalTrials.gov Identifier: NCT01509521     History of Changes
Other Study ID Numbers: 2011-006103-35, SJ-271
Study First Received: January 8, 2012
Last Updated: August 5, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Naestved Hospital:
Spectroscopy, Near-Infrared
Fetal heartrate
Ephedrine
Phenylephrine

Additional relevant MeSH terms:
Ephedrine
Phenylephrine
Oxymetazoline
Pseudoephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Respiratory System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Cardiotonic Agents
Mydriatics
Protective Agents

ClinicalTrials.gov processed this record on July 28, 2014