Clinical trial NCT04367103: Norepinephrine for Hypotension in Cesarean Section
Official title: Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Cesarean Section
Keywords: post spinal anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hypotensive episodes.
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Incidence of maternal bradycardia.
timeFrame: 15-20 minutes
measure: Incidence of reactive hypertension
timeFrame: 20 minutes
measure: nausea and vomiting
timeFrame: 20 minutes
measure: Total dose of vasopressor
timeFrame: 20 minutes
Other outcomes:
measure: Fetal outcome
timeFrame: at 1, 5 and 8 minutes
measure: mixed blood gas
timeFrame: 1 minute after delivery
measure: Admission to neonatal ICU (NICU)
timeFrame: first 24 hours after delivery
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Mohamed M. Abdellatif, M.D.
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Shimaa A. Husien, M.D.
role: PRINCIPAL_INVESTIGATOR
References: