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

NCT ID: NCT00432991

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Nausea; Vomiting; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Saline Placebo

Drug: Saline Placebo 0.5 mL, IM (in the muscle), one time

Group Type: PLACEBO_COMPARATOR

Saline Placebo

Intervention Type: DRUG

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

IM Ephedrine

Drug: Ephedrine \[Synonyms: Ephedra, Ephedrinum\] 25 mg, IM (in the muscle), one time

Group Type: EXPERIMENTAL

Ephedrine [Synonyms: Ephedra, Ephedrinum]

Intervention Type: DRUG

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

Interventions

Ephedrine [Synonyms: Ephedra, Ephedrinum]

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

Intervention Type: DRUG

Saline Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Abramovitz, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

New York-Presbyterian Hospital; Weill Medical College of Cornell

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34002866 (View on PubMed)

Other Identifiers

0609008727

Identifier Type: -

Identifier Source: org_study_id