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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine | Active Comparator |
| |
| Lower limb compression | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Invasive arterial bloodpressure | Until end of operation, up to roughly 1 hour |
| 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jana Christine Kuhn, Dr.med. | Bærum sykehus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bærum Sykehus | Rud | Akershus | 1309 | Norway |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Lower limb compression | Device | Tight bandaging of lower extremity up to hips with compression bandages |
|
| Placebo | Other | Neither phenylephrine nor lower limb bandaging |
|
| Until end of operation, roughly 1 hour |
| Cardiac Output | Until end of operation, roughly 1 hour |
| D000588 |
| Amines |