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Trial record 21 of 536 for:    decongestants

Effects of Norepinephrine-ephedrine Combination on Maternal Hemodynamics

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ClinicalTrials.gov Identifier: NCT03672071
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Celaleddin Soyalp, Yuzuncu Yıl University

Brief 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. Secondary aim of the study is to investigate the effect of this combination on neonatal Apgar score and umbilical cord blood gas values.

Condition or disease Intervention/treatment Phase
Cesarean Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline) Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized prospective controlled study
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effectivity of Combined Use of Ephedrine and Norepinephrine on Maternal Hemodynamics in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 1, 2018


Arm Intervention/treatment
Group E
If 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,
Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
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

Group NE
.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,
Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
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

Group N
. 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,
Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)
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




Primary Outcome Measures :
  1. systolic arterial blood pressure [ Time Frame: during operation ]
    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

  2. diastolic arterial blood pressure [ Time Frame: during operation ]
    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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Term pregnant patients
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term pregnant patients.

Exclusion Criteria:

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

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): NCT03672071


Contacts
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Contact: CELALEDDİN SOYALP 5068456504 c.soyalp@hotmail.com
Contact: YUZKAT NUREDDIN +905052294728 nyuzkat@gmail.com

Locations
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Turkey
Celaleddin Soyalp Recruiting
VAN, Turkey, 65080
Contact: celaleddin soyalp    5068456504    c.soyalp@hotmail.com   
Contact: YUZKAT NUREDDIN    +905052294728    nyuzkat@gmail.com   
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Principal Investigator: CELALEDDİN SOYALP Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey

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Responsible Party: Celaleddin Soyalp, Assist. prof., Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03672071     History of Changes
Other Study ID Numbers: cesarean
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celaleddin Soyalp, Yuzuncu Yıl University:
ephedrine
norepinephrine
maternal hemodynamics
spinal anesthesia

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Norepinephrine
Pseudoephedrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Central Nervous System Stimulants
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents