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Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT02354833
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Manuel C. Vallejo MD , DMD, West Virginia University

Brief Summary:
The purpose of the study is to determine if a medication called phenylephrine, which helps to control blood pressure, is more effective as a continuous intravenous (IV) infusion compared to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Good blood pressure control 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 morphine (provides long term pain control after cesarean delivery). This study plans to enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Condition or disease Intervention/treatment Phase
Effects of; Anesthesia, in Labor and Delivery Drug: Phenylephrine Drug: Norepinephrine Phase 4

Detailed Description:

This study will be a prospective, experimental, observational, randomized open label, 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: A continuous phenylephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% of baseline before the spinal.

Group B will consist of: A continuous norepinephrine infusion 0.05 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% 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. IV will be placed. Intravenous ondansetron 4 mg and up to 500 mL of Lactated Ringers solution administered prior to induction of spinal anesthesia.

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, 10 = worst possible nausea). Patients will also be instructed to report episodes of nausea at any other time during the study. Emesis will be recorded whenever present during the surgical procedure.

Hypertensive episodes (SBP greater than 120% of baseline) will be treated with cessation of infusion. Infusion will be restarted when SBP has decreased to below the upper limit of the target range (120% of baseline SBP). If the infusion must be stopped on three occasions, it will be discontinued permanently and the blood pressure maintained with phenylephrine boluses only.

Bradycardia (HR less than 50 BPM) will be treated with glycopyrrolate 0.4mg IV or ephedrine 5 mg - 10 mg IV bolus.

Study participants will receive a standard spinal anesthetic consisting of 0.75% hyperbaric bupivacaine (1.6 mL) plus preservative free morphine (0.2 mg) and fentanyl (20 mcg) at L3-4 or L4-5 interspace (the standard of care for spinal anesthesia at Ruby Memorial Hospital). Prior to surgical incision, the spinal sensory level will be tested to the bilateral T4 dermatomal level which is necessary for cesarean section under spinal anesthesia. The patients will be positioned supine with a wedge placed under the right hip to avoid aortocaval compression. Both the patient and the clinical research assistant (who will collect data) will not be blinded as to the administered phenylephrine infusion or norepinephrine infusion. The study will end when care is transferred to the labor and delivery room nurse.

Measured variables will include blood pressure (BP), the number and type of provider interventions for control of blood pressure (BP), heart rate (HR), cardiac output (CO) as measured by a noninvasive CO monitor, APGAR scores at 1 and 5 minutes, nausea and vomiting, and fetal cord blood analysis at delivery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phenylephrine vs. Norepinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Delivery
Study Start Date : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: Phenylephrine
A continuous phenylephrine infusion at 0.1 mcg/kg/min
Drug: Phenylephrine
Experimental: Norepinephrine
A continuous norepinephrine infusion at 0.05 mcg/kg/min
Drug: Norepinephrine
Other Name: Levophed




Primary Outcome Measures :
  1. Number of Rescue Boluses to Maintain SBP [ Time Frame: At time of surgery, up to 2 hours ]
    Number of rescue boluses to maintain the SBP within 100-120% of baseline

  2. Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP [ Time Frame: At time of surgery, up to 2 hours ]
  3. Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP [ Time Frame: At time of surgery, up to 2 hours ]

Secondary Outcome Measures :
  1. Percentage of Participants Experiencing Both Nausea and Emesis [ Time Frame: At time of surgery, up to 2 hours ]


Information from the National Library of Medicine

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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:

  • The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
  • Pregnant women with singleton pregnancy
  • Gestational age greater than 36 weeks
  • Cesarean delivery under spinal anesthesia

Exclusion Criteria:

  • Use of cardiac medication or medication for blood pressure control
  • Cardiovascular disease
  • Multiple gestation
  • Gestation diabetes requiring insulin
  • History of postoperative nausea and vomiting
  • Refusal to be in study
  • Gastric bypass surgery
  • History of chronic opioid use (chronic pain syndrome)
  • Emergent caesarean delivery for maternal and/or fetal distress
  • Eclampsia
  • Progressive neurologic disease
  • Infection at insertion site
  • Allergy to local anesthetics, narcotics or other study medications.

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): NCT02354833


Locations
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United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Publications:

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Responsible Party: Manuel C. Vallejo MD , DMD, Chair; Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT02354833    
Other Study ID Numbers: 1406316590
First Posted: February 3, 2015    Key Record Dates
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017
Last Verified: January 2017
Keywords provided by Manuel C. Vallejo MD , DMD, West Virginia University:
Hypotension
Cesarean Delivery
Phenylephrine
Spinal Anesthesia
Norepinephrine
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Norepinephrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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