Norepinephrine to Prevent Hypotension in Ceasrean Delivery

NCT05248932 | Completed Phase 4

• 1 other identifier: 19919ANET33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Cesarean Section Complications

Keywords

hypotension; norepinephrine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• umblical cord gases sample

  in the first minute after delivery

• APGAR score

  after 5 minutes and 10 minutes after delivery

• Non invasive MEAN blood pressure

  every 10 minutes and up tp 1 hour

• Heart rate

  every 10 minutes and up to 1 hour

Study Arms (2)

infusion

ACTIVE COMPARATOR

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; Drug: Norepinephrine infusion

bolus

ACTIVE COMPARATOR

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.

Drug: Norepinephrine bolus; Device: cardiometry

Interventions

Norepinephrine bolus DRUG

5 microgram bolus therapy

bolus

cardiometry DEVICE

cardiac output, stroke volume and fluid responsiveness monitoring

bolus; infusion

Norepinephrine infusion DRUG

2.5 microgram/min infusion

infusion

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: pregnant females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 21, 2022
• Study Start: January 20, 2021
• Primary Completion: May 20, 2022
• Study Completion: June 20, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)