Clinical trial NCT00432991: Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
Official title: A Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Intramuscular Ephedrine on the Incidence of Perioperative Nausea and Vomiting During Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea
Vomiting
Cesarean Section
Keywords: Nausea
Vomiting
Cesarean Section
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2007-02-09
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Pre-Induction Nausea Score
timeFrame: immediately pre-induction
measure: 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.
timeFrame: intra-operation
measure: Post-Operation Nausea Score
timeFrame: post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York-Presbyterian Hospital; Weill Medical College of Cornell
state: New York
Study officials:
affiliation: Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital
name: Sharon Abramovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.