Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

Study Overview
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Brief Summary
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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.

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

Conditions
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Caesarean Section

Intervention / Treatment
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* Drug: Phenylephrine
* Device: Lower limb compression
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypotension, Caesarean section, Spinal anaesthesia, Lower limb compression / wrapping, Phenylephrine