Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia

NCT03421860 | Completed Phase 4

• 1 other identifier: bich-fel
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the cardiac output changes after an intravenous bolus of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a cesarean delivery. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study includes 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of four groups.

Conditions

Cardiac Output, Low

Keywords

Spinal anesthesia; cardiac output; vasopressor

Outcome Measures

Primary Outcomes (1)

• cardiac output changes for 120 patients

  In left lateral tilt position, cardiac output is calculated on the echocardiographic apical cut 5 cavities, every 5 minutes till delivery, with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine. The cardiac output is calculated on the apical cut 5 cavities: Dc (cm3 / min) = ITV \* S \* HR Dc = cardiac output ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut. Only the closing click (B2) is visible. If B2 is not visible, the sample is placed too much in the hunting chamber, which underestimates the ITV. If B1 and B2 are visible, the sample is too close to the aortic ring, which overestimates the ITV measurement. S = surface area of the aortic ring = (aorta diameter) ₂ \* π / 4 The diameter of the aorta is the average of three measurements at the beginning of systole, on the major axis.

  at time of delivery (right after spinal anesthesia until delivery)

Secondary Outcomes (5)

• Maternal Blood Pressure

  at time of delivery (right after spinal anesthesia until delivery)

• heart rate

  at time of delivery (right after spinal anesthesia until delivery)

• Vomiting

  at time of delivery (right after spinal anesthesia until delivery)

• mean pH of the fetal cord blood

  at time of delivery (right after spinal anesthesia until delivery)

• Nausea

  at time of delivery (right after spinal anesthesia until delivery)

Study Arms (4)

ephedrine

ACTIVE COMPARATOR

will receive ephedrine :a bolus of 9 mg after SA once intervention: will receive complementary doses of ephedrine 6 mgto maintain systolic blood pressure above 80 % of baseline

Drug: cardiac output changes with "ephedrine"

phenylephrine

ACTIVE COMPARATOR

will receive Phenylephrine : a bolus of 100 mcg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline

Drug: cardiac output changes with "phenylephrine"

ondansetron

ACTIVE COMPARATOR

will receive ondansetron: a bolus of 8 mg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline

Drug: cardiac output changes with "ondansetron"

norepinephrine

ACTIVE COMPARATOR

will receive noradrenaline (norepinephrine) a bolus of 0,25 mcg/kg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline

Drug: cardiac output changes with "nor-epinephrine"

Interventions

cardiac output changes with "ephedrine" DRUG

measure cardiac output after giving a bolus of ephedrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR . ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.

ephedrine

cardiac output changes with "phenylephrine" DRUG

measure cardiac output after giving a bolus of phenylephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.

phenylephrine

cardiac output changes with "ondansetron" DRUG

measure cardiac output after giving a bolus of ondansetron intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.

ondansetron

cardiac output changes with "nor-epinephrine" DRUG

measure cardiac output after giving a bolus of nor-epinephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Also known as: cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.

norepinephrine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I / II
• Caesarean section, non-twinned

You may not qualify if:

• heart disease
• HTA
• non-gestational diabetes
• pre-eclampsia
• sepsis
• BMI greater than 40
• contraindication to spinal anesthesia: patient refusal, medicinal allergy, long QT syndrome.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Ephedrine; Cardiac Output; Phenylephrine; Ondansetron

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Ethanolamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• hayen maghrebi, professor

  tunis maternity center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, assistant professor

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: February 5, 2018
• Study Start: February 23, 2017
• Primary Completion: February 23, 2018
• Study Completion: March 30, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)