Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

NCT00956215 | Completed DMC

• 1 other identifier: Emend
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.

Conditions

Nausea; Vomiting

Keywords

post operative; obese

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of 80mg Aprepitant in preventing post operative nausea or vomiting in morbidly obese patients (BMI of 45 kg/m2 or higher) undergoing upper gastrointestinal surgery.

  72 hours

Study Arms (2)

80mg of Aprepitant

ACTIVE COMPARATOR

Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia.

Drug: Aprepitant

80 mg of placebo

PLACEBO COMPARATOR

. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.

Drug: Aprepitant placebo

Interventions

Aprepitant DRUG

80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery

80mg of Aprepitant

Aprepitant placebo DRUG

80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.

80 mg of placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects included in this study must be:
• Female
• At least 18 years of age
• Non-smoking
• At high risk for PONV
• Obese with a BMI of at least 45 kg/m2
• Undergoing upper gastrointestinal surgery requiring postoperative opioid analgesia

You may not qualify if:

• Subjects will be excluded if:
• They have a known allergy to Aprepitant or Ondansetron
• They are currently taking Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride)
• They are pregnant
• They are breastfeeding
• They plan on getting pregnant in the 2 months following surgery
• They are not able to receive patient controlled analgesia (PCA) following surgery
• They have a known drug or alcohol abuse problem
• They have chronic nausea and vomiting

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting; Obesity

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ashish Sinha, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

US (1)