Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients

NCT00738621 | Completed Phase 4 DMC

• 1 other identifier: Scott and White
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of the use of oral aprepitant in combination with intravenous ondansetron and dexamethasone with the efficacy provided by the use of oral aprepitant and dexamethasone for preventing vomiting during the first 24-48 hours after breast surgery.

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; breast surgery; prevention; antiemetics

Outcome Measures

Primary Outcomes (1)

• Compare the efficacy of the use of oral aprepitant in combination with intravenous ondansetron and dexamethasone with the efficacy provided by the use of oral aprepitant in combination with dexamethasone alone for preventing vomiting for 1st 24hrs

  2 yrs

Secondary Outcomes (1)

• Compare efficacy of oral aprepitant in combination with IV ondansetron and dexamethasone with efficacy of dexamethasone and oral aprepitant alone for preventing vomiting during the 24-48 hours after breast surgery

  2 yrs

Study Arms (2)

1

ACTIVE COMPARATOR

Oral aprepitant 40 mg - given within 3 hours prior to induction dexamethasone (4mg intravenous) administered immediately after induction ondansetron (4mg (2ml) intravenous) administered at cessation of anesthesia

Drug: Aprepitant, Dexamethasone, Ondansetron

A,2

PLACEBO COMPARATOR

Oral aprepitant 40 mg- given within 3 hours prior to induction dexamethasone (4mg intravenous) administered immediately after induction Placebo ( intravenous saline 2ml) administered at cessation of anesthesia

Drug: Aprepitant, Dexamethasone, Placebo

Interventions

Aprepitant, Dexamethasone, Ondansetron DRUG

Aprepitant oral 40mg one dose, dexamethasone IV 4mg one dose, ondansetron 4 mg one dose

Also known as: Emend=aprepitant

1

Aprepitant, Dexamethasone, Placebo DRUG

Aprepitant 40mg oral one time, dexamethasone IV 4mg one time placebo one time

Also known as: Emend=aprepitant

A,2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following criteria must be met for the potential subject to be eligible for participation:
• The subject is a female scheduled to undergo ambulatory breast surgery performed under general anesthesia
• The subject is expected to undergo general inhalation anesthesia.
• The subject presents with two of the three following high-risk factors associated with PONV (must be in their medical history in order to be eligible)
• She is a non-smoker.
• She has documented history of PONV and/or motion sickness.
• She is expected to receive intra-operative and postoperative opioid.
• The subject's American Society of Anesthesiologist physical status is ASA I-III
• The subject is between18 to 65 years of age.
• The subject is expected to be discharged from the hospital/surgical center on the same day as the surgery.
• The subject has provided written informed consent to participate in the study.

You may not qualify if:

• The subject has a history of allergic reaction to, intolerances of or contraindications for any of the study medications or required anesthetic agents.
• The subject has received or is expected to receive any excluded preoperative drug within 48 hours prior to induction; or is expected to receive any excluded intra-operative or postoperative medications.
• The subject is pregnant or lactating. (If the potential subject is pre-menopausal, a urine pregnancy test must be performed within 24 hours/1 day of study prior to the planned surgery time and confirmed negative in order for the potential subject to be enrolled).
• The subject is taking warfarin.
• The subject has a history of alcohol and/or drug abuse within 1 year of study medication, or has a positive screening or pre-study test for alcohol or drugs of abuse.
• The subject is expected to require the use of a nasogastric tube postoperatively.
• The subject has a diagnosed latex allergy.
• The subject has used oral aprepitant (Emend®) within the last 30 days.
• The subject has participated in a randomized study or has been exposed to any experimental drug within 30 days prior to enrollment of this study.

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Scott and White Healthcare

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Tricia A Meyer, PharmD

  Scott and White Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 19, 2013

Record last verified: 2008-08

Locations

US (1)