Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section - Full Text View

Sponsor:	Weill Medical College of Cornell University
Collaborator:	New York Presbyterian Hospital
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00432991

Purpose

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	Intervention	Phase
Nausea Vomiting Cesarean Section	Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum] Drug: Saline Placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section Nausea and Vomiting Surgery

Drug Information available for: Ephedrine Hydrochloride Ephedrine Pseudoephedrine hydrochloride Pseudoephedrine Sulfate

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Subject's self-rated nausea level on a scale of 0-3 at multiple points immediately before, during, and after the surgery [ Time Frame: before surgery, multiple times during & after surgery ] [ Designated as safety issue: No ]
Investigator's rating of the incidence of vomiting or retching on a scale of 0-3 at multiple points immediately before, during, and after the surgery [ Time Frame: before surgery, multiple times during & after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Non-invasive blood pressure measurements made during the procedure [ Time Frame: once each minute for at least 10 minutes and then at least every 2.5 minutes for the duration of the surgery ] [ Designated as safety issue: No ]
Total amount of vasopressors (total IV ephedrine and total IV phenylephrine) administered during the procedure [ Time Frame: throughout the surgery ] [ Designated as safety issue: No ]
Cord Blood Gas Results following delivery of the placenta [ Time Frame: one time, after delivery of placenta ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	February 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Saline Placebo 0.5 mL, IM (in the muscle), one time
2: Experimental IM Ephedrine	Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum] 25 mg, IM (in the muscle), one time

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

Ages Eligible for Study:	18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432991

Contacts

Contact: Rachel Brody, RN	212-746-2952	rab9027@med.cornell.edu
Contact: Sharon Abramovitz, MD	212-746-2679	sea2003@med.cornell.edu

Locations

United States, New York
New York-Presbyterian Hospital; Weill Medical College of Cornell	Recruiting
New York, New York, United States, 10021
Principal Investigator: Sharon Abramovitz, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

New York Presbyterian Hospital

Investigators

Principal Investigator:

Sharon Abramovitz, MD

Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital

More Information

No publications provided

Responsible Party:	Weill Cornell Medical College, Dept of Anesthesiology ( Sharon Abramovitz, MD )
Study ID Numbers:	0609008727
Study First Received:	February 7, 2007
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00432991 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Nausea
Vomiting
Cesarean Section

Additional relevant MeSH terms:

Pseudoephedrine
Respiratory System Agents
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Signs and Symptoms, Digestive
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents

Pharmacologic Actions
Nasal Decongestants
Signs and Symptoms
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Nausea
Ephedrine
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009