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Nausea | Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries

Nausea research study

What is the primary objective of this study?

The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.

Who is eligible to participate?

Inclusion Criteria: - at least 18 years old - ASA physical status I-III - must have at least 2 risk factors for PONV Exclusion Criteria: - pregnant or breast feeding patients - antiemetic medication in previous 24 hours - allergy or other contraindication to study medications

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nausea

Vomiting

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DexamethasoneDexamethasone 5 mg administered intravenously following endotracheal intubation

Drug:AprepitantAprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Drug:Placebo Dexamethasone

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Active ComparatorPatients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting

Placebo ComparatorPatients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting

Study Status

Unknown status

Start Date: February 2009

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: the incidences of nausea, vomiting, need for rescue medication

Secondary Outcome: incidences of unplanned hospital admission; duration of PACU stay

Study sponsors, principal investigator, and references

Principal Investigator: Dmitri Chamchad, MD

Lead Sponsor: Main Line Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00835965

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