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NCT Number: NCT00432991

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

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.

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Key information

Conditions

Nausea Cesarean Section Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

New York-Presbyterian Hospital; Weill Medical College of Cornell

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine [Synonyms: Ephedra, Ephedrinum]

Drug

25 mg, IM (in the muscle), one time

Saline placebo

Drug

0.5 mL, IM (in the muscle), one time

Primary outcomes

  1. Pre-Induction Nausea Score

    Time frame: immediately pre-induction

    Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea

  2. 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.

    Time frame: intra-operation

    Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin.

    The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject.

  3. Post-Operation Nausea Score

    Time frame: post-operation

    Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU.

    The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • New York Presbyterian Hospital

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2007
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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