Phase 2 Completed N=53 Randomized Double-blind Prevention

Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section

Nausea · Vomiting · Cesarean section

Source: ClinicalTrials.gov NCT00432991 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcomePrimary: Pre-Induction Nausea Score — 0.067; 0 units on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pre-Induction Nausea Score	0.067; 0	—
PRIMARY Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.	0.16; 0.28	—
PRIMARY Post-Operation Nausea Score	0.067; 0.53	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00432991). 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. Informational only — not medical advice.