Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

NCT ID: NCT04245891

Last Updated: 2020-01-29

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

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-11-30

Brief Summary

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This retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. The main objective is to compare the initial Apgar score. The records of patients who received norepinephrine are compared to those without norepinephrine. To limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, ASA score, comorbidity, urgency. The patients analysed correspond to the period 2016-2017.

Detailed Description

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Conditions

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Caesarean Section;Stillbirth

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control group

boli of ephedrine phenylephrine (45μg/mL-3mg/mL) if the variation of MAP \< 20% of baseline (MAP before spinal anaesthesia).

No interventions assigned to this group

Protocol group

continuous infusion of norepinepineprhine at 20 μg/mL, started at 0.05 μg/kg/min. The dosage of norepinephrine was then adjusted to maintain a variation in MAP \< 20% of baseline. In case of failure, the use of a control group boli injection was possible.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age \> 18
* Spinal Anesthesia for Cesarean Section

Exclusion Criteria

* sub epidural cesarean section
* contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IRB 17.11.01

Identifier Type: -

Identifier Source: org_study_id

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