Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation
Primary Purpose
Preeclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ephedrine
Phenylephrine
Metaraminol
Sponsored by
About this trial
This is an interventional diagnostic trial for Preeclampsia focused on measuring Vasopressor, Cesarian delivery, Hypotension, Maternal cardiac output, Uteroplacental blood flow, Cerebral fetal blood flow, Preeclampsia
Eligibility Criteria
Inclusion Criteria:
- Preeclampsia patients
- After 34 weeks pregnant
Exclusion Criteria:
- Patients' refusal
- Obstetric Emergency
- Contraindications to spinal anesthesia
- Obesity
Sites / Locations
- University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ephedrine Group
Phenylephrine Group
Metaraminol
Arm Description
Patients who will receive ephedrine after spinal anesthesia
Patients who will receive Phenylephrine after spinal anesthesia
Patients who will receive Metaraminol after spinal anesthesia
Outcomes
Primary Outcome Measures
Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.
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.
Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia
Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.
Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use
Secondary Outcome Measures
Full Information
NCT ID
NCT02245191
First Posted
August 7, 2014
Last Updated
September 16, 2014
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02245191
Brief Title
Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Vasopressor, Cesarian delivery, Hypotension, Maternal cardiac output, Uteroplacental blood flow, Cerebral fetal blood flow, Preeclampsia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ephedrine Group
Arm Type
Experimental
Arm Description
Patients who will receive ephedrine after spinal anesthesia
Arm Title
Phenylephrine Group
Arm Type
Experimental
Arm Description
Patients who will receive Phenylephrine after spinal anesthesia
Arm Title
Metaraminol
Arm Type
Experimental
Arm Description
Patients who will receive Metaraminol after spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Intervention Description
5mg after Spinal Anesthesia
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
100mcg after Spinal Anesthesia
Intervention Type
Drug
Intervention Name(s)
Metaraminol
Intervention Description
200mcg Metaraminol after Spinal Anesthesia
Primary Outcome Measure Information:
Title
Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.
Description
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.
Time Frame
One year
Title
Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia
Time Frame
One year
Title
Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.
Time Frame
One year
Title
Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preeclampsia patients
After 34 weeks pregnant
Exclusion Criteria:
Patients' refusal
Obstetric Emergency
Contraindications to spinal anesthesia
Obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Bliacheriene, MD
Organizational Affiliation
Instituto do Coracao
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation
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