Phase 4
N=81
Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery
Effects of; Anesthesia, in Labor and Delivery
Bottom Line
View on ClinicalTrials.gov: NCT02354833 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Rescue Boluses to Maintain SBP — 25; 21 rescue boluses — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Phenylephrine (Drug); Norepinephrine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- West Virginia University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Rescue Boluses to Maintain SBP |
25; 21 | 0.12 |
| PRIMARY Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP |
0; 0 | 0.10 |
| PRIMARY Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP |
50; 100 | 0.73 |
| SECONDARY Percentage of Participants Experiencing Both Nausea and Emesis |
63.2; 51.2; 26.3; 16.3 | 0.28 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02354833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.