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Norepinephrine to Prevent Hypotension in Ceasrean Delivery

Primary Purpose

Hypotension, Cesarean Section Complications

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Norepinephrine bolus
cardiometry
Norepinephrine infusion
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring hypotension, norepinephrine

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I & II
  • Non laboring
  • Normotensive
  • Elective cesarean delivery under spinal anesthesia.
  • Baseline systolic blood pressure 90-140 mm Hg

Exclusion Criteria:

  • Known fetal abnormality.
  • Preexisting or pregnancy-induced hypertension.
  • Known cardiovascular or cerebrovascular disease.
  • Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.
  • Weight <50 or >100 kg, height <140 or >180 cm.
  • Inability or refusal to give informed consent

Sites / Locations

  • Faculty of Medicine, University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

infusion

bolus

Arm Description

patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline

patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value.

Outcomes

Primary Outcome Measures

throracic volume variations change from baseline
using cardiometry
cardiac index change from baseline
using cardiometry
systemic vascular resistance change from baseline
using cardiometry
stroke volume variation change from baseline
using cardiometry

Secondary Outcome Measures

umblical cord gases sample
APGAR score
score from 1 to 10 with the highest score better for neonatal outcome
Non invasive MEAN blood pressure
change from baseline
Heart rate
change from baseline

Full Information

First Posted
December 29, 2021
Last Updated
October 12, 2022
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05248932
Brief Title
Norepinephrine to Prevent Hypotension in Ceasrean Delivery
Official Title
Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia 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
This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.
Detailed Description
Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee. All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile. Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection. 10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr. Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5. The patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Cesarean Section Complications
Keywords
hypotension, norepinephrine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
infusion
Arm Type
Active Comparator
Arm Description
patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline
Arm Title
bolus
Arm Type
Active Comparator
Arm Description
patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine bolus
Intervention Description
5 microgram bolus therapy
Intervention Type
Device
Intervention Name(s)
cardiometry
Intervention Description
cardiac output, stroke volume and fluid responsiveness monitoring
Intervention Type
Drug
Intervention Name(s)
Norepinephrine infusion
Intervention Description
2.5 microgram/min infusion
Primary Outcome Measure Information:
Title
throracic volume variations change from baseline
Description
using cardiometry
Time Frame
every 10 minutes up to 1 hour
Title
cardiac index change from baseline
Description
using cardiometry
Time Frame
every 10 minutes up to 1 hour
Title
systemic vascular resistance change from baseline
Description
using cardiometry
Time Frame
every 10 minutes up to 1 hour
Title
stroke volume variation change from baseline
Description
using cardiometry
Time Frame
every 10 minutes and up to 1 hour
Secondary Outcome Measure Information:
Title
umblical cord gases sample
Time Frame
in the first minute after delivery
Title
APGAR score
Description
score from 1 to 10 with the highest score better for neonatal outcome
Time Frame
after 5 minutes and 10 minutes after delivery
Title
Non invasive MEAN blood pressure
Description
change from baseline
Time Frame
every 10 minutes and up tp 1 hour
Title
Heart rate
Description
change from baseline
Time Frame
every 10 minutes and up to 1 hour

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I & II Non laboring Normotensive Elective cesarean delivery under spinal anesthesia. Baseline systolic blood pressure 90-140 mm Hg Exclusion Criteria: Known fetal abnormality. Preexisting or pregnancy-induced hypertension. Known cardiovascular or cerebrovascular disease. Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia. Weight <50 or >100 kg, height <140 or >180 cm. Inability or refusal to give informed consent
Facility Information:
Facility Name
Faculty of Medicine, University Hospitals
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Norepinephrine to Prevent Hypotension in Ceasrean Delivery

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