We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00432991
Recruitment Status : Completed
First Posted : February 9, 2007
Results First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Cesarean Section Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum] Drug: Saline Placebo Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : February 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Saline Placebo
Drug: Saline Placebo 0.5 mL, IM (in the muscle), one time
 Drug: Saline Placebo
0.5 mL, IM (in the muscle), one time
Experimental: IM Ephedrine
Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum] 25 mg, IM (in the muscle), one time
 Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum]
25 mg, IM (in the muscle), one time


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432991


Locations
Layout table for location information
United States, New York
New York-Presbyterian Hospital; Weill Medical College of Cornell
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sharon Abramovitz, MD Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00432991    
Other Study ID Numbers: 0609008727
First Posted: February 9, 2007    Key Record Dates
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weill Medical College of Cornell University:
Nausea
Vomiting
Cesarean Section
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Signs and Symptoms, Digestive
Ephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action