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

NCT00432991 | Completed Phase 2 Results

• 1 other identifier: 0609008727
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting; Cesarean Section

Keywords

Nausea; Vomiting; Cesarean Section

Outcome Measures

Primary Outcomes (3)

• Pre-Induction Nausea Score

  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

  immediately pre-induction

• 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.

  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.

  intra-operation

• Post-Operation Nausea Score

  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.

  post-operation

Study Arms (2)

Saline Placebo

PLACEBO COMPARATOR

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

Drug: Saline Placebo

IM Ephedrine

EXPERIMENTAL

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

Drug: Ephedrine [Synonyms: Ephedra, Ephedrinum]

Interventions

Ephedrine [Synonyms: Ephedra, Ephedrinum] DRUG

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

IM Ephedrine

Saline Placebo DRUG

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

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• New York Presbyterian Hospital: collaborator

Study Sites (1)

New York-Presbyterian Hospital; Weill Medical College of Cornell

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ephedrine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Michele Steinkamp, Research Nurse Specialist
• Organization: Weill Cornell Medicine, Department of Anesthesiology

mls9004@med.cornell.edu

212-746-2953

Study Officials

• Sharon Abramovitz, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 9, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 22, 2017
• Results First Posted: May 22, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)