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Cardiac Output Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia (EPhON)

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ClinicalTrials.gov Identifier: NCT03421860
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

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.


Condition or disease Intervention/treatment Phase
Cardiac Output, Low Drug: cardiac output changes with "ephedrine" Drug: cardiac output changes with "phenylephrine" Drug: cardiac output changes with "ondansetron" Drug: cardiac output changes with "nor-epinephrine" Phase 4

Detailed Description:

This study will be a prospective, randomized, double-blind controlled trial. After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 4 treatment groups prior to cesarean delivery.

Group A: 9 mg of ephedrine Group B: 100 mcg of phenylephrine Group C: 8 mg of ondansetron Group D: 0,25 mcg/kg of norepinephrine Baseline arterial blood pressure and heart rate will be measured in the left lateral tilt position, before anesthesia and then every minute.The cardiac output is calculated on the apical cut 5 cavities, before anesthesia and then every 5 miutes. No fluid preloading will be administered till delivery.

The primary endpoint is cardiac output changes in each groups. The secondary endpoint is the number of provider interventions needed to maintain the SBP within 80-120% of baseline for each groups.

Bradycardia (HR less than 50 BPM) will be treated with 1 mg of Atropine. Hypotension ( decrease of more than 20% of the baseline value or a PAS <90 mm Hg) will be treated with 6 mg of ephedrine, without any fluid loading.

The spinal anesthesia will be carried out in a seated position, level L3-L4 or L4-L5 with a slow injection over 30 seconds of a mixture of 10 mg of 0.5% Bupivacaine with 5 mcg of Sufentanil. The hot / cold test to determine the block level is required. A spinal anesthesia is validated if the cold test reaches the T4 level. The 10 ml syringe will be administered immediately after spinal anesthesia. The patient will be placed in the left lateral tilt position of 15¤, then put back into strict DD immediately after the delivery. Cardiovascular parameters (PAS, PAM, PAD, HR) will be recorded every minute until delivery. Echocardiographic measurement of cardiac output will be recorded every five minutes until delivery.

Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, cardiac output, incidence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Cardiac Output Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia for Cesarian Section
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : February 23, 2018
Estimated Study Completion Date : March 30, 2018


Arm Intervention/treatment
Active Comparator: ephedrine
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"
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
Other Name: 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.

Active Comparator: phenylephrine
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"
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
Other Name: 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.

Active Comparator: ondansetron
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"
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
Other Name: 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.

Active Comparator: norepinephrine
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"
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
Other Name: 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.




Primary Outcome Measures :
  1. cardiac output changes for 120 patients [ Time Frame: at time of delivery (right after spinal anesthesia until delivery) ]

    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.



Secondary Outcome Measures :
  1. Maternal Blood Pressure [ Time Frame: at time of delivery (right after spinal anesthesia until delivery) ]
    Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean delivery with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine

  2. heart rate [ Time Frame: at time of delivery (right after spinal anesthesia until delivery) ]
    mean heart rate during cesarean delivery with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine

  3. Vomiting [ Time Frame: at time of delivery (right after spinal anesthesia until delivery) ]
    incidence of Vomiting during cesarean section with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine

  4. mean pH of the fetal cord blood [ Time Frame: at time of delivery (right after spinal anesthesia until delivery) ]
    fetal cord blood analysis will be done immediately after delivery in order to determine the pH value in each group

  5. Nausea [ Time Frame: at time of delivery (right after spinal anesthesia until delivery) ]
    incidence of nausea during cesarean section with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421860


Contacts
Contact: SOFIENE BEN MARZOUK, MD 0021699941968 BMARZOUKSOFIENE@LIVE.FR
Contact: hayen maghrebi, professor 00216683905 hayen.maghrebi@yahoo.fr

Locations
Tunisia
Tunis maternity and neonatology center, minisetry of public health Recruiting
Tunis, Tunisia, 1007
Contact: Hayen Maghrebi, professor    0021622921379    hayen.maghrebi@yahoo.fr   
Sponsors and Collaborators
University Tunis El Manar
Investigators
Study Chair: hayen maghrebi, professor tunis maternity center

Responsible Party: Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03421860     History of Changes
Other Study ID Numbers: bich-fel
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Ben marzouk Sofiene, University Tunis El Manar:
Spinal anesthesia
cardiac output
vasopressor

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Anesthetics
Benzocaine
Ondansetron
Epinephrine
Racepinephrine
Epinephryl borate
Phenylephrine
Oxymetazoline
Norepinephrine
Ephedrine
Pseudoephedrine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents