Norepinephrine for Hypotension in Cesarean Section

Norepinephrine or Phenylephrine for Hypotension in Non-elective 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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Cesarean Section
• Intervention / Treatment: Drug: Norepinephrine; Drug: Phenylephrine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NEP group; Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.	Drug: Norepinephrine; prophylaxis for hypotension; Other Names: noradrenaline
Placebo Comparator: PHE group; Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.	Drug: Phenylephrine; standerd prophylaxis for hypotension; Other Names: phenylephrine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotensive episodes.	Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg.	15-20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of maternal bradycardia.	Bradycardia is defined as heart rate (HR) < 50 beats/min	15-20 minutes
Incidence of reactive hypertension	defined as >120% of baseline.	20 minutes
nausea and vomiting	Incidence of nausea and vomiting attacks.	20 minutes
Total dose of vasopressor	Total dose of vasopressor used.	20 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal outcome	APGAR score	at 1, 5 and 8 minutes
mixed blood gas	Umbilical artery and vein blood gas	1 minute after delivery
Admission to neonatal ICU (NICU)	the need for NICU admission	first 24 hours after delivery

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed M. Abdellatif, M.D., Assiut University; Principal Investigator: Shimaa A. Husien, M.D., Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: post spinal anesthesia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Norepinephrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: ShA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No