Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery

Completed · Phase 4

Conditions studied: Effects of; Anesthesia, in Labor and Delivery

In brief

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.

Key facts

Study ID

NCT02354833

Run by

West Virginia University

People needed

85

Starts

2014-08-01

Expected to finish

2015-08-01

Last updated by the study team

2017-01-04

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• West Virginia University Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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