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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432991
• Other study ID #: 0609008727
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2007
• Last updated: June 13, 2013
• Start date: February 2007
• Est. completion date: September 2010

Study information

• Verified date: June 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 ( 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section
• Nausea
• Vomiting

Intervention

Drug:
• Ephedrine [Synonyms: Ephedra, Ephedrinum]
25 mg, IM (in the muscle), one time
• Saline Placebo
0.5 mL, IM (in the muscle), one time

Locations

Country	Name	City	State
United States	New York-Presbyterian Hospital; Weill Medical College of Cornell	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's self-rated nausea level on a scale of 0-3 at multiple points immediately before, during, and after the surgery		before surgery, multiple times during & after surgery	No
Primary	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		before surgery, multiple times during & after surgery	No
Secondary	Non-invasive blood pressure measurements made during the procedure		once each minute for at least 10 minutes and then at least every 2.5 minutes for the duration of the surgery	No
Secondary	Total amount of vasopressors (total IV ephedrine and total IV phenylephrine) administered during the procedure		throughout the surgery	No
Secondary	Cord Blood Gas Results following delivery of the placenta		one time, after delivery of placenta	No