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Trial record 20 of 540 for:    decongestants

Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation

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ClinicalTrials.gov Identifier: NCT02245191
Recruitment Status : Unknown
Verified May 2014 by University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
It is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Ephedrine Drug: Phenylephrine Drug: Metaraminol Not Applicable

Detailed Description:
Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable for mother and child when referring to the side effects, including hypotension. The choice of the best vasopressor in this context is approaching to a resolution, favoring phenylephrine use. However, studies on high-risk pregnancies are still required, such as uteroplacental insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol, making a total of three groups with 20 patients each. Variables to be analyzed are uterine arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean arterial blood pressure and maternal peripheral vascular resistance. These variables will be recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after vasopressor bolus. Averages will be calculated in these intervals and then compared to the alteration caused by spinal anesthesia and the return to basal levels after drug intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation in Patients With Preeclampsia Under Spinal Anesthesia for Cesarean
Study Start Date : July 2014
Actual Primary Completion Date : July 2014


Arm Intervention/treatment
Experimental: Ephedrine Group
Patients who will receive ephedrine after spinal anesthesia
Drug: Ephedrine
5mg after Spinal Anesthesia

Experimental: Phenylephrine Group
Patients who will receive Phenylephrine after spinal anesthesia
Drug: Phenylephrine
100mcg after Spinal Anesthesia

Experimental: Metaraminol
Patients who will receive Metaraminol after spinal anesthesia
Drug: Metaraminol
200mcg Metaraminol after Spinal Anesthesia




Primary Outcome Measures :
  1. Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use. [ Time Frame: One year ]
    The main purpose of this study is evaluate if one of related drugs (ephedrine, phenylephrine or metaraminol) is superior than others to keep the maternal cardiac output, uteroplacental and fetal cerebral bloodflow despite the hemodynamic changes that is peculiar after spinal anesthesia.

  2. Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia [ Time Frame: One year ]
  3. Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use. [ Time Frame: One year ]
  4. Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preeclampsia patients
  • After 34 weeks pregnant

Exclusion Criteria:

  • Patients' refusal
  • Obstetric Emergency
  • Contraindications to spinal anesthesia
  • Obesity

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): NCT02245191


Locations
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Brazil
University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Fernando Bliacheriene, MD Instituto do Coracao

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02245191     History of Changes
Other Study ID Numbers: VASPRES-3
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: May 2014

Keywords provided by University of Sao Paulo General Hospital:
Vasopressor
Cesarian delivery
Hypotension
Maternal cardiac output
Uteroplacental blood flow
Cerebral fetal blood flow
Preeclampsia

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anesthetics
Phenylephrine
Oxymetazoline
Metaraminol
Pseudoephedrine
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Bronchodilator Agents
Anti-Asthmatic Agents