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Aprepitant for Post-operative Nausea

NCT ID: NCT01020903

Last Updated: 2023-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aprepitant

Group Type ACTIVE_COMPARATOR

Aprepitant

Intervention Type PROCEDURE

40 mg po pre-op

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally, pre-op

Interventions

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Aprepitant

40 mg po pre-op

Intervention Type PROCEDURE

Placebo

Orally, pre-op

Intervention Type DRUG

Other Intervention Names

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Emend Sugar pill

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Staten Island University Hospital

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Silverberg, MD

Role: PRINCIPAL_INVESTIGATOR

Staten Island University Hospital

Locations

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Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10365008 (View on PubMed)

Other Identifiers

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09-045

Identifier Type: -

Identifier Source: org_study_id