Aprepitant for Post-operative Nausea

NCT01020903 | Completed Results

• 1 other identifier: 09-045
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.

Conditions

Postoperative Nausea

Outcome Measures

Primary Outcomes (1)

• Post-operative Nausea and Vomiting

  Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.

  1 year

Study Arms (2)

Aprepitant

ACTIVE COMPARATOR

Procedure: Aprepitant

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aprepitant PROCEDURE

40 mg po pre-op

Also known as: Emend

Aprepitant

Placebo DRUG

Orally, pre-op

Also known as: Sugar pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Laparoscopic cholecystectomy patients.
• Must be able to swallow a pill.

You may not qualify if:

• Liver failure,
• Age less than 18.
• Pregnancy, breast-feeding.
• Pre-op vomiting.
• Allergy to aprepitant.
• Need for post-op gastric drainage.
• Use of drugs that interact with aprepitant.

Sponsors & Collaborators

• Northwell Health: lead
• Staten Island University Hospital: collaborator

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Related Publications (1)

• Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274.

  PMID: 10365008 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant; Sugars

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; Carbohydrates

Results Point of Contact

• Title: Michael Silverberg/Principal Investigator
• Organization: Staten Island University Hospital

msilverberg@siuh.edu

718-226-6629

Study Officials

• Michael B Silverberg, MD

  Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 24, 2009
• First Posted: November 26, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 22, 2023
• Results First Posted: June 4, 2015

Record last verified: 2023-11

Locations

US (1)