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CesareanNCT03672071

Effects of Norepinephrine-ephedrine Combination on Maternal Hemodynamics

A study testing Ephedrine, Noradrenaline ,ephedrine+Noradrenaline) in people with Cesarean, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to investigate the effect of combined use of Ephedrine and Norepinephrine on maternal hemodynamics in patients undergoing cesarean delivery under spinal anesthesia. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Cesarean
What is being tested?
Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Sep 2018to 1 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Term pregnant patients.

Who cannot join

  • A maternal cardiac diseases
  • Pulmonary diseases
  • Placenta previa
  • Placental abruption
  • Intrauterine fetal death
  • Expectancy for a syndromic child
  • İntrauterine growth restriction
  • Preeclampsia

Trial locations and contacts

1 site in 1 country.

CELALEDDİN SOYALP contact

5068456504

c.soyalp@hotmail.com

YUZKAT NUREDDIN contact

+905052294728

nyuzkat@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Celaleddin Soyalp

    Van, 65080

    celaleddin soyalp, 5068456504, c.soyalp@hotmail.com

    YUZKAT NUREDDIN, +905052294728, nyuzkat@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effectivity of Combined Use of Ephedrine and Norepinephrine on Maternal Hemodynamics in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia

The aim of this study is to investigate the effect of combined use of Ephedrine and Norepinephrine on maternal hemodynamics in patients undergoing cesarean delivery under spinal anesthesia. Secondary aim of the study is to investigate the effect of this combination on neonatal Apgar score and umbilical cord blood gas values.

Read the detailed description

The study will have a double-blind design and will include 90 patients planned for elective cesarean delivery aged 18-45 years with an ASA score of I-II who will be randomized by sealed tender and will be divided into 3 groups with 30 patients each. The exclusion criteria will be as follows: conversion to general anesthesia, an ASA score of III and IV, emergency surgery, hemodynamic instability, maternal cardiac and pulmonary diseases, placenta previa, placental abruption, intrauterine fetal death, expectancy for a syndromic child, intrauterine growth restriction, preeclampsia, a history of allergy to Ephedrine and Norepinephrine, and neonatal intubation after birth due to respiratory distress or other causes. Each patient will undergo physical examination and laboratory testing one day prior to the procedure. On the same day, each patient will be given information about spinal anesthesia and cesarean delivery under spinal anesthesia, and the patients consenting to participate will be included in the study.

Each patient will undergo preoperative examination 30 min prior to the surgery. After establishing intravenous access, crystalloid fluid 10 cc/kg will be injected. The patient will then be transferred to the operating table. Routine monitorization will be performed and preoperative hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), and blood oxygen saturation (SpO2) will be recorded for each patient.

Spinal Anesthesia Procedure: After placing the patient in the sitting position and ensuring asepsis and antisepsis, the spinal L3-L4 intercostal space will be palpated and 10 mg 0.05% bupivacaine and 25 microgram fentanyl will be administered using a 25-gauge Quincke needle after viewing the cerebrospinal fluid through the arachnoid space, followed by withdrawal of the needle and administration of pressure dressing. Subsequently, the table will be tilted to the left side by 15 degrees and O2 gas flow will be administered through a nasal cannula at a flow rate of 2 L/min. Following the assessment of dermatomal level, surgical procedure will be initiated.

Throughout the surgical procedure, hemodynamic parameters will be recorded using noninvasive methods every 2 min. If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, 5 mg Ephedrine, 5 mg Noradrenaline, and 5 mg Ephedrine + 2.5 mg Noradrenaline i.v. will be administered in Groups E, N, and EN, respectively. On the other hand, surgical details including the total number of vasoactive agent administrations and the length of intervals between administrations, frequency of side effects including nausea, vomiting, discomfort, and headache, Apgar scores at min 1 and 5, umbilical cord blood gas values, duration of surgery, and demographic characteristics (e.g. age, height, weight, parity) will be recorded for each patient and will be used for statistical analysis

Conditions
Cesarean
Being tested
Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
Keywords
ephedrine, norepinephrine, maternal hemodynamics, spinal anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)Other

    If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups

Study groups in NCT03672071
Study groupRoleWhat they receive
Group EOtherIf a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Ephedrine i.v. will be administered to patient will be performed. In the case of hypotension,
Receives: Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
Group NEOther.If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Noradrenaline, i.v. will be administered to patient will be performed. In the case of hypotension,
Receives: Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
Group NOther. If a 20% decrease in parameter compared to their baseline levels is sustained, necessary interventions mg Ephedrine + 2.5 mg Noradrenaline i.v. will be administered to patient will be performed. In the case of hypotension,
Receives: Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. systolic arterial blood pressure

    The maximal aortic pressure following ejection is termed the systolic pressure.Throughout the surgical procedure, it will be recorded using noninvasive methods every 2 minute as mm/Hg

    Measured: during operation

  2. diastolic arterial blood pressure

    The lowest pressure in the aorta, which occurs just before the ventricle ejects blood into the aorta, is termed the diastolic pressure.Throughout the surgical procedure, it will be recorded using noninvasive methods every 2 minute as mm/Hg

    Measured: during operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start30 Sep 2018 (estimated)
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion1 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized prospective controlled study
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672071
Sponsor's protocol ID
cesarean
Status last verified
Aug 2018
First submitted
4 Aug 2018
Last updated
14 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Ephedrine, Noradrenaline ,ephedrine+Noradrenaline) in people with Cesarean, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact CELALEDDİN SOYALP (5068456504, c.soyalp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

systolic arterial blood pressure (time frame: during operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.

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