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OpenTrials
Completed

NCT Number: NCT01278238

Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

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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Key information

Conditions

Caesarean Section Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bærum Sykehus

Rud, Akershus, 1309, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

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

Lower limb compression

Device

Tight bandaging of lower extremity up to hips with compression bandages

Placebo

Other

Neither phenylephrine nor lower limb bandaging

Primary outcomes

  1. Invasive arterial bloodpressure

    Time frame: Until end of operation, up to roughly 1 hour

Secondary outcomes

  1. pH value from umbilical vessels of the newborn

    Time frame: straight after delivery

  2. APGAR score of the newborn

    Time frame: 1 + 5 + 10 minutes after delivery

  3. Need for rescue pressor (ephedrine, phenylephrine)

    Time frame: Until end of operation, roughly 1 hour

  4. Cardiac Output

    Time frame: Until end of operation, roughly 1 hour

Sponsors and collaborators

Lead sponsor

Anestesiavdelingen Baerum Sykehus

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 17, 2011
Registry last updated
Jan 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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