Norepinephrine to Prevent Hypotension in Ceasrean Delivery

Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.

This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Hypotension
• Intervention / Treatment: Device: cardiometry; Drug: Norepinephrine infusion; Drug: Norepinephrine bolus

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32511
      • Faculty of Medicine, University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: infusion; 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	Device: cardiometry; cardiac output, stroke volume and fluid responsiveness monitoring; Drug: Norepinephrine infusion; 2.5 microgram/min infusion
ACTIVE_COMPARATOR: bolus; 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.	Device: cardiometry; cardiac output, stroke volume and fluid responsiveness monitoring; Drug: Norepinephrine bolus; 5 microgram bolus therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
throracic volume variations change from baseline	using cardiometry	every 10 minutes up to 1 hour
cardiac index change from baseline	using cardiometry	every 10 minutes up to 1 hour
systemic vascular resistance change from baseline	using cardiometry	every 10 minutes up to 1 hour
stroke volume variation change from baseline	using cardiometry	every 10 minutes and up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
umblical cord gases sample		in the first minute after delivery
APGAR score	score from 1 to 10 with the highest score better for neonatal outcome	after 5 minutes and 10 minutes after delivery
Non invasive MEAN blood pressure	change from baseline	every 10 minutes and up tp 1 hour
Heart rate	change from baseline	every 10 minutes and up to 1 hour

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ACTUAL): May 20, 2022
• Study Completion (ACTUAL): June 20, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (ACTUAL): February 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: norepinephrine; hypotension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: 19919ANET33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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