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Norepinephrine for Hypotension in Cesarean Section

Primary Purpose

Hypotension, Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Norepinephrine
Phenylephrine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring post spinal anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NEP group

PHE group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2020
Last Updated
December 30, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04367103
Brief Title
Norepinephrine for Hypotension in Cesarean Section
Official Title
Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Cesarean Section
Keywords
post spinal anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEP group
Arm Type
Active Comparator
Arm Description
Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.
Arm Title
PHE group
Arm Type
Placebo Comparator
Arm Description
Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
noradrenaline
Intervention Description
prophylaxis for hypotension
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
phenylephrine hydrochloride
Intervention Description
standerd prophylaxis for hypotension
Primary Outcome Measure Information:
Title
Incidence of hypotensive episodes.
Description
Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg.
Time Frame
15-20 minutes
Secondary Outcome Measure Information:
Title
Incidence of maternal bradycardia.
Description
Bradycardia is defined as heart rate (HR) < 50 beats/min
Time Frame
15-20 minutes
Title
Incidence of reactive hypertension
Description
defined as >120% of baseline.
Time Frame
20 minutes
Title
nausea and vomiting
Description
Incidence of nausea and vomiting attacks.
Time Frame
20 minutes
Title
Total dose of vasopressor
Description
Total dose of vasopressor used.
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
Fetal outcome
Description
APGAR score
Time Frame
at 1, 5 and 8 minutes
Title
mixed blood gas
Description
Umbilical artery and vein blood gas
Time Frame
1 minute after delivery
Title
Admission to neonatal ICU (NICU)
Description
the need for NICU admission
Time Frame
first 24 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M. Abdellatif, M.D.
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shimaa A. Husien, M.D.
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

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Norepinephrine for Hypotension in Cesarean Section

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