The Oxygenation of the Brain During Caesarean Section

Complications; Cesarean Section Clinical Trial

— OBDUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509521
• Other study ID #: 2011-006103-35
• Secondary ID: SJ-271
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2012
• Last updated: August 5, 2012
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications; Cesarean Section

Intervention

Drug:
• Ephedrine
An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.
• Phenylephrine
An infusion of maximum 4 mg/hour for maximum 60 minutes.

Locations

Country	Name	City	State
Denmark	Naestved Hospital	Naestved

Sponsors (2)

Lead Sponsor	Collaborator
Naestved Hospital	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frontal lobe cerebral oxygenation	Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	Yes
Primary	Foetal heartrate	From before induction of spinal anaesthesia to 15 min after delivery	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	Yes
Secondary	Mean arterial pressure	The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery.	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	Yes
Secondary	Cardiac output	The cardiac output is measures from before induction of spinal anaesthesia to end of surgery.	Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour	Yes
Secondary	Umbilical cord pH and Base excess	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.	Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.	Yes