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OpenTrials
Completed

NCT Number: NCT04367103

Norepinephrine for Hypotension in Cesarean Section

Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, 71515, Egypt

About this study

Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.

Exclusion criteria

  • Patient refusal either to study enrollment or to spinal anesthesia.
  • Any absolute contraindication to spinal anesthesia e.g. coagulopathy, skin infection at site of injection.
  • Allergy to any of study drugs.
  • Patients with cardiac morbidities, hypertensive disorders or peripartum bleeding
  • BMI > 40 kg/m²
  • Baseline systolic blood pressure < 100 mmHg.

Treatment and study plan

norepinephrine

Drug

prophylaxis for hypotension

Other names: noradrenaline

Phenylephrine

Drug

standerd prophylaxis for hypotension

Other names: phenylephrine hydrochloride

Primary outcomes

  1. Incidence of hypotensive episodes.

    Time frame: 15-20 minutes

    Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg.

Secondary outcomes

  1. Incidence of maternal bradycardia.

    Time frame: 15-20 minutes

    Bradycardia is defined as heart rate (HR) < 50 beats/min

  2. Incidence of reactive hypertension

    Time frame: 20 minutes

    defined as >120% of baseline.

  3. nausea and vomiting

    Time frame: 20 minutes

    Incidence of nausea and vomiting attacks.

  4. Total dose of vasopressor

    Time frame: 20 minutes

    Total dose of vasopressor used.

Other outcomes

  1. Fetal outcome

    Time frame: at 1, 5 and 8 minutes

    APGAR score

  2. mixed blood gas

    Time frame: 1 minute after delivery

    Umbilical artery and vein blood gas

  3. Admission to neonatal ICU (NICU)

    Time frame: first 24 hours after delivery

    the need for NICU admission

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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