Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section (NECS)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Caesarean Section;Stillbirth

Study type: Observational

Funder types: Other

Identifiers

NCT04245891

IRB 17.11.01

Details and patient eligibility

About

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.

Enrollment: 265 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18
• Spinal Anesthesia for Cesarean Section

Exclusion criteria

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

Trial design

265 participants in 2 patient groups

Control group

Description:

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

Protocol group

Description:

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.