Norepinephrine for Hypotension in Cesarean Section

Not Applicable

Completed

• Conditions: Hypotension; Cesarean Section
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT04367103
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-29
• Study Start: 2021-04-10
• Primary Completion: 2022-05-04
• Study Completion: 2022-05-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHE group	Phenylephrine	Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.
NEP group	Norepinephrine	Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.

Primary Outcome Measures

Name	Time	Method
Incidence of hypotensive episodes.	15-20 minutes	Hypotension is defined as \<80% of baseline or systolic blood pressure (SBP) \<100 mmHg.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt