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Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia (NorPN)

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ClinicalTrials.gov Identifier: NCT02854787
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

Brief Summary:
The purpose of the study is to determine if an intravenous bolus of phenylephrine is more effective compared to an intravenous bolus of norepinephrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Condition or disease Intervention/treatment Phase
Anesthesia, Spinal and Epidural Adverse Effect Hypotension Complications, Cesarean Section Drug: Phenylephrine Drug: Norepinephrine Phase 4

Detailed Description:

This study will be a prospective, randomized, active treatment controlled trial.

After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.

Group A will consist of: An intravenous bolus of 0,2 mcg/Kg of norepinephrine to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.

Group B will consist of: An intravenous bolus of 100mcg of phenylephrine to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.

Patients will be admitted to holding area. Baseline arterial blood pressure and heart rate will be measured in supine position, with left uterine displacement. Baseline blood pressure will be calculated by taking the mean of three consecutive SBP measurements taken 5 minutes apart. 500 mL of Lactated Ringers solution will be administered immediately after induction of spinal anesthesia at the outflow rate of 100ml per hour.

The primary endpoint is the number of provider interventions needed to maintain the SBP within 100-120% of baseline for both groups. The secondary endpoint is nausea measured with each provider intervention after induction of spinal anesthesia, and immediately following delivery with 11 point verbal rating scale (0 = no nausea, 1 = nausea). Vomiting will be recorded whenever present during the surgical procedure.

Bradycardia (HR less than 50 BPM) will be treated with Atropine 0.4mg IV or ephedrine 3 mg - 12 mg IV bolus.

Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus sufentanil (5 mcg) at L3-4 or L4-5. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Phenylephrine or norepinephrine bolus. The study will end when cesarean section is completed and the patient transferred to the post-operative care unit.

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, 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: Prevention
Official Title: Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
Study Start Date : May 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Active Comparator: Phenylephrine
A bolus of 100 mcg
Drug: Phenylephrine
A bolus of 100 mcg
Active Comparator: Norepinephrine
A bolus of 0,2 mcg/kg
Drug: Norepinephrine
A bolus of 0,2 mcg/kg
Other Names:
  • Noraline
  • Noradrénaline



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


Secondary Outcome Measures :
  1. Hemodynamic Parameters - heart rate [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery ]
    mean heart rate during cesarean section with an infusion of either Ephedrine or Norepinephrine

  2. Hemodynamic Parameters - arrhythmia [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    incidence of arrhythmic events during cesarean section with an infusion of either Ephedrine or Norepinephrine

  3. Vomiting [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    incidence of Vomiting (V) during cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no vomiting; 1= vomiting

  4. mean pH of the fetal cord blood in each group [ Time Frame: At time of birth ]
    fetal cord blood analysis will be done immediately after delivery in order to determine the pH value ( ie: logarithm of the blood concentration of hydrogen ions H+)in each group

  5. Nausea [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    cesarean section with an infusion of either Ephedrine or Norepinephrine. Measure will be done according to a simple scale: 0= no nausea; 1= nausea



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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:

  • of Anesthesiologists (ASA) Physical Status classification 1 and 2
  • Pregnant women with singleton pregnancy

Exclusion Criteria:


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): NCT02854787


Locations
Tunisia
Tunis maternity and neonatology center, minisetry of public health
Tunis, Tunisia, 1007
Sponsors and Collaborators
University Tunis El Manar

Responsible Party: Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT02854787     History of Changes
Other Study ID Numbers: UniversityTunis el manar
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ben marzouk Sofiene, University Tunis El Manar:
Spinal anesthesia
cesarean
blood pressure
Norepinephrine
Phenylephrine

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Phenylephrine
Oxymetazoline
Norepinephrine
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents