Norepinephrine for Hypotension in Cesarean Section

Hypotension Clinical Trial

Official title:

Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367103
• Other study ID #: ShA
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: May 4, 2022

Study information

• Verified date: December 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension

Intervention

Drug:
• Norepinephrine
prophylaxis for hypotension
• Phenylephrine
standerd prophylaxis for hypotension

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fetal outcome	APGAR score	at 1, 5 and 8 minutes
Other	mixed blood gas	Umbilical artery and vein blood gas	1 minute after delivery
Other	Admission to neonatal ICU (NICU)	the need for NICU admission	first 24 hours after delivery
Primary	Incidence of hypotensive episodes.	Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg.	15-20 minutes
Secondary	Incidence of maternal bradycardia.	Bradycardia is defined as heart rate (HR) < 50 beats/min	15-20 minutes
Secondary	Incidence of reactive hypertension	defined as >120% of baseline.	20 minutes
Secondary	nausea and vomiting	Incidence of nausea and vomiting attacks.	20 minutes
Secondary	Total dose of vasopressor	Total dose of vasopressor used.	20 minutes