Norepinephrine for Hypotension in Cesarean Section

Assiut University

Status: Completed

Conditions: Hypotension; Cesarean Section

Treatments: Drug: Norepinephrine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04367103

ShA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

180 participants in 2 patient groups, including a placebo group

NEP group

Active Comparator group

Description:

Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.

Treatment:

Drug: Norepinephrine

PHE group

Placebo Comparator group

Description:

Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.

Treatment:

Drug: Phenylephrine