Health Trials

Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section (INPEACE)

ConditionsCesarean Section ComplicationsHypotension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHassan II University

About this trial

The goal of this clinical trial is to compare norepinephrine and ephedrine in maintaining blood pressure during spinal anaesthesia for elective cesarean delivery. The main questions it aims to answer are:

* Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on neonatal outcome ? * Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on maternal hemodynamics? Participants will receive either phenylephrine or norepinephrine infusion, at the time of performing spinal anesthesia, the infusion rate will be adjusted manually depending on maternal arterial pressure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Full-term, singleton, pregnant women, nonlaboring.

Scheduled for elective cesarean delivery under spinal anesthesia,

American Society of Anesthesiologists physical status : 1 or 2

Baseline systolic BP between 90 and 140 mm Hg.

Disqualifiers

Known fetal abnormality.

Preexisting or pregnancy-induced hypertension, cardiovascular, cerebrovascular or kidney disease.

Contraindication to spinal anesthesia.

Peripartum hemorrhage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous infusion of Norepinephrine

    Drug

    The rate of norepinephrine infusion will be adjusted according to values of systolic blood pressure measured noninvasively and recorded at 1-minute intervals along the intraoperative period, with the objective of maintaining values near baseline.

  • Continuous infusion of Phenylephrine

    Drug

    The rate of phenylephrine infusion will be adjusted according to values of systolic blood pressure measured noninvasively and recorded at 1-minute intervals along the intraoperative period, with the objective of maintaining values near baseline.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: PhenylephrineActive comparator 1 intervention
Group B: NorepinephrineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Umbilical artery pH

Umbilical arterial blood (UA) will be sampled from a double-clamped segment of umbilical cord by using arterial blood gas syringes.Umbilical blood gas will be analyzed with a bedside Blood gas Analyzer System.

Time frame
Immediately after delivery

Secondary outcomes

1

Umbilical artery base excess

From umbilical arterial blood gases.

Time frame
Immediately after delivery
2

Umbilical artery partial pressure of oxygen

From umbilical arterial blood gases.

Time frame
Immediately after delivery
3

Umbilical artery partial pressure of carbon dioxide

From umbilical arterial blood gases

Time frame
Immediately after delivery
4

APGAR score

A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration. Values of APGAR score vary from 0 to 10, higher scores mean a better outcome.

Time frame
1 min after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hassan II University

Lead sponsor

Source ClinicalTrials.gov
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