Norepinephrine for Hypotension in Cesarean Section

NCT04367103 | Completed

• 1 other identifier: ShA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Cesarean Section

Keywords

post spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotensive episodes.

  Hypotension is defined as \<80% of baseline or systolic blood pressure (SBP) \<100 mmHg.

  15-20 minutes

Secondary Outcomes (4)

• Incidence of maternal bradycardia.

  15-20 minutes

• Incidence of reactive hypertension

  20 minutes

• nausea and vomiting

  20 minutes

• Total dose of vasopressor

  20 minutes

Other Outcomes (3)

• Fetal outcome

  at 1, 5 and 8 minutes

• mixed blood gas

  1 minute after delivery

• Admission to neonatal ICU (NICU)

  first 24 hours after delivery

Study Arms (2)

NEP group

ACTIVE COMPARATOR

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

Drug: Norepinephrine

PHE group

PLACEBO COMPARATOR

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

Interventions

Norepinephrine DRUG

prophylaxis for hypotension

Also known as: noradrenaline

NEP group

Phenylephrine DRUG

standerd prophylaxis for hypotension

Also known as: phenylephrine hydrochloride

PHE group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mohamed M. Abdellatif, M.D.

  Assiut University

  STUDY DIRECTOR

• Shimaa A. Husien, M.D.

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 29, 2020
• Study Start: April 10, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

EG (1)