The Oxygenation of the Brain During Caesarean Section

Study Overview
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Brief Summary
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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.

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

Conditions
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Complications; Cesarean Section

Intervention / Treatment
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* Drug: Ephedrine
* Drug: Phenylephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ephedrine<br> | Drug: Ephedrine<br>* An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.<br>* Other names: Ephedrine hydrochloride;|
| Active Comparator: Phenylephrine<br> | Drug: Phenylephrine<br>* An infusion of maximum 4 mg/hour for maximum 60 minutes.<br>* Other names: Metaoxedrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frontal lobe cerebral oxygenation | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ephedrine, Spectroscopy, Near-Infrared, Fetal heartrate, Phenylephrine