Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

NCT00659945 | Completed Phase 4 Results DMC

• 1 other identifier: PRO07070325
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after surgery. Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up to 48 hours after surgery.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperation, nausea, vomiting, anesthesia, plastic surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants Having Post-operative Emesis and Nausea.

  Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS\>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.

  48 hours post surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Pre-op Aprepitant plus Ondansetron for PONV prophylaxis in patients undergoing outpatient plastic surgery

Drug: Aprepitant plus Ondansetron

2

PLACEBO COMPARATOR

Pre-op Placebo plus Ondansetron for PONV prophylaxis in patients undergoing outpatient plastic surgery

Drug: Ondansetron plus placebo

Interventions

Aprepitant plus Ondansetron DRUG

Aprepitant plus Ondansetron

Also known as: Emend

1

Ondansetron plus placebo DRUG

Ondansetron plus placebo

Also known as: Zofran

2

Eligibility Criteria

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

You may qualify if:

• Written informed consent
• ASA (American Society of Anesthesiologists physical status) 1-3
• Male and female Age 18 to 65 years
• Plastic surgical procedure (Breast, Face, Liposuction, etc., and excluding peripheral procedures such as hand surgery and limited-scope split-thickness skin grafts) of at least 1 hour in duration
• General anesthesia
• Presence of 2 (men)/3 (women) or more risk factors for PONV
• Ambulatory surgery with same-day discharge planned

You may not qualify if:

• Patient refusal
• Patients who have received other antiemetics prior to their procedure
• History of allergy or sensitivity to study drugs
• Pregnancy - Patients are asked date of last menstrual period, use of birth control, tubal ligation, if they have had unprotected sexual intercourse and if they think if there is any possibility of being pregnant, and when appropriate, a pregnancy test will be obtained which is the standard of care at Magee-Womens Hospital.
• Patients with a history of chronic opioid use (chronic pain syndrome) as these patients will be less likely to have PONV

Sponsors & Collaborators

• University of Pittsburgh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Aprepitant; Ondansetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Manuel C. Vallejo, MD
• Organization: University of Pittsburgh

vallejomc@anes.upmc.edu

412-641-4260

Study Officials

• Manuel C Vallejo, MD

  Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept. of Anesthesiology

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 17, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: June 1, 2010
• Last Updated: February 6, 2013
• Results First Posted: December 7, 2011

Record last verified: 2013-02

Locations

US (1)