Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery (NCT02354833) | Clinical Trial Compass
CompletedPhase 4
Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery
United States85 participantsStarted 2014-08
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Rescue Boluses to Maintain SBP
Timeframe: At time of surgery, up to 2 hours
2
Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP
Timeframe: At time of surgery, up to 2 hours
3
Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP