The Oxygenation of the Brain During Caesarean Section (OBDUC)

Naestved Hospital

Status and phase: Completed; Phase 4

Conditions: Complications; Cesarean Section

Treatments: Drug: Phenylephrine; Drug: Ephedrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01509521

SJ-271 (Other Identifier)

2011-006103-35

Details and patient eligibility

About

The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy pregnant women
• Over 18 years old
• ASA 1-2
• Undergoing elective caesarean section
• Height over 160 cm or under 180 cm

Exclusion criteria

• Allergic reactions to ephedrine or phenylephrine
• High blood levels of bilirubin
• HELPP syndrome
• Preeclampsia (pregnancy-induced hypertension)
• Non singleton pregnancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Ephedrine

Active Comparator group

Treatment:

Drug: Ephedrine

Phenylephrine

Active Comparator group

Treatment:

Drug: Phenylephrine