Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

Caesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278238
• Other study ID #: 2009-013025-42
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: January 9, 2013
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Anestesiavdelingen Baerum Sykehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Statens LegemiddelverkNorway: Regional Etisk KomiteNorway: Personvernombudet
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caesarean Section

Intervention

Drug:
• Phenylephrine
Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

Device:
• Lower limb compression
Tight bandaging of lower extremity up to hips with compression bandages

Other:
• Placebo
Neither phenylephrine nor lower limb bandaging

Locations

Country	Name	City	State
Norway	Bærum Sykehus	Rud	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
Anestesiavdelingen Baerum Sykehus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive arterial bloodpressure		Until end of operation, up to roughly 1 hour	No
Secondary	pH value from umbilical vessels of the newborn		straight after delivery	No
Secondary	APGAR score of the newborn		1 + 5 + 10 minutes after delivery	No
Secondary	Need for rescue pressor (ephedrine, phenylephrine)		Until end of operation, roughly 1 hour	No
Secondary	Cardiac Output		Until end of operation, roughly 1 hour	No