OBDUC: The Oxygenation of the Brain During Caesarean Section

Sponsor

Naestved Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01509521

Collaborator

Rigshospitalet, Denmark (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Complications; Cesarean Section	Drug: Ephedrine Drug: Phenylephrine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ephedrine	Drug: Ephedrine An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope. Other Names: Efedrin Ephedrine hydrochloride
Active Comparator: Phenylephrine	Drug: Phenylephrine An infusion of maximum 4 mg/hour for maximum 60 minutes. Other Names: Phenylephrine Hydrochloride Metaoxedrin

Arm

Intervention/Treatment

Active Comparator: Ephedrine

Drug: Ephedrine

An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.

Other Names:

Efedrin

Ephedrine hydrochloride

Active Comparator: Phenylephrine

Drug: Phenylephrine

An infusion of maximum 4 mg/hour for maximum 60 minutes.

Other Names:

Phenylephrine Hydrochloride

Metaoxedrin

Outcome Measures

Primary Outcome Measures

Frontal lobe cerebral oxygenation [Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour]
Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.
Foetal heartrate [Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour]
From before induction of spinal anaesthesia to 15 min after delivery

Secondary Outcome Measures

Mean arterial pressure [Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour]
The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery.
Cardiac output [Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour]
The cardiac output is measures from before induction of spinal anaesthesia to end of surgery.
Umbilical cord pH and Base excess [Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.]
The umbilical cord blood analysis for evaluation of the newborn's acid-base status is taken immediately after delivery. It is the most objective way of assessing the fetal metabolic condition at birth.