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Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

Not Applicable
Completed
Conditions
Caesarean Section
Interventions
Other: Placebo
Device: Lower limb compression
Registration Number
NCT01278238
Lead Sponsor
Anestesiavdelingen Baerum Sykehus
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
Lower limb compressionLower limb compression-
PhenylephrinePhenylephrine-
Primary Outcome Measures
NameTimeMethod
Invasive arterial bloodpressureUntil end of operation, up to roughly 1 hour
Secondary Outcome Measures
NameTimeMethod
Need for rescue pressor (ephedrine, phenylephrine)Until end of operation, roughly 1 hour
pH value from umbilical vessels of the newbornstraight after delivery
APGAR score of the newborn1 + 5 + 10 minutes after delivery
Cardiac OutputUntil end of operation, roughly 1 hour

Trial Locations

Locations (1)

Bærum Sykehus

🇳🇴

Rud, Akershus, Norway

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