The Oxygenation of the Brain During Caesarean Section

NCT ID: NCT01509521

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Complications; Cesarean Section

Keywords

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Spectroscopy, Near-Infrared Fetal heartrate Ephedrine Phenylephrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ephedrine

Group Type ACTIVE_COMPARATOR

Ephedrine

Intervention Type DRUG

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

Phenylephrine

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

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

Interventions

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Ephedrine

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

Intervention Type DRUG

Phenylephrine

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

Intervention Type DRUG

Other Intervention Names

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Efedrin Ephedrine hydrochloride Phenylephrine Hydrochloride Metaoxedrin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Naestved Hospital

OTHER

Sponsor Role lead

Responsible Party

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Visti Foss

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Visti Foss

Role: PRINCIPAL_INVESTIGATOR

Naestved Hospital

Locations

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Naestved Hospital

Næstved, , Denmark

Site Status

Countries

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Denmark

References

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Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.

Reference Type DERIVED
PMID: 32619039 (View on PubMed)

Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014.

Reference Type DERIVED
PMID: 24624090 (View on PubMed)

Other Identifiers

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SJ-271

Identifier Type: OTHER

Identifier Source: secondary_id

2011-006103-35

Identifier Type: -

Identifier Source: org_study_id