Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a Cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.
Full description
This research project is designed to study the medication ephedrine, when it is given as a routine part of the anesthesia for elective Cesarean section. Ephedrine is a medication that is widely used in labor and in vaginal and operative (Cesarean section) deliveries to help maintain a woman's blood pressure within its normal range, especially after spinal and epidural anesthesia has been administered. The purpose of this study is to determine if ephedrine, when given intramuscularly (<IM> as a shot in the muscle), at the time of spinal anesthesia administration, can help to decrease the incidence of nausea and vomiting subjects experience during and after a Cesarean section. This study will compare women who receive ephedrine to a similar group of women who receive a normal saline placebo. In addition to looking at the difference in the incidence of nausea and vomiting perioperatively, this study will also evaluate if the administration of IM ephedrine helps the baby to receive more blood from the placenta after anesthesia has been administered to the mother. This will be evaluated by performing a simple blood test, drawn from the umbilical cord, after the baby is born.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Must be pregnant with a single baby
- Must be at term in their pregnancy (estimated gestational age of at least 38 weeks)
- Must be scheduled for an elective Cesarean section
- Must be between 60-70" tall
- Must be free of severe systemic disease (ASA class I or II)
Exclusion criteria
- Contraindication to spinal anesthesia
- Any allergy to any of the medications included in the study
- History of pregnancy-induced hypertension or preeclampsia
- History of preexisting hypertension
- Diabetes mellitus
- Hyperemesis gravidum
- Previous perioperative nausea and vomiting
- History of motion sickness
- Women carrying a fetus with a known abnormality will also be excluded from the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
53 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal