Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

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

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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