Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278238

Enrollment

120

Registered

2011-01-17

Start date

2010-01-31

Completion date

2012-10-31

Last updated

2013-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section

Keywords

Hypotension, Caesarean section, Spinal anaesthesia, Lower limb compression / wrapping, Phenylephrine

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.

Interventions

DRUGPhenylephrine

Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

DEVICELower limb compression

Tight bandaging of lower extremity up to hips with compression bandages

OTHERPlacebo

Neither phenylephrine nor lower limb bandaging

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Invasive arterial bloodpressure	Until end of operation, up to roughly 1 hour

Secondary

Measure	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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026