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Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

A

Anestesiavdelingen Baerum Sykehus

Status

Completed

Conditions

Caesarean Section

Treatments

Other: Placebo
Drug: Phenylephrine
Device: Lower limb compression

Study type

Interventional

Funder types

Other

Identifiers

NCT01278238
2009-013025-42

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 3 patient groups, including a placebo group

Phenylephrine
Active Comparator group
Treatment:
Drug: Phenylephrine
Lower limb compression
Active Comparator group
Treatment:
Device: Lower limb compression
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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