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

Primary Purpose

Nausea, Vomiting

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Aprepitant

Placebo Dexamethasone

About this trial

This is an interventional prevention trial for Nausea focused on measuring Laparoscopic, Surgery, Postoperative, Nausea, Vomiting, Aprepitant, Dexamethasone, Postoperative Nausea, Postoperative Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lankenau Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator

Placebo Comparator

Arm Description

Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting

Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting

Outcomes

Primary Outcome Measures

the incidences of nausea, vomiting, need for rescue medication

Secondary Outcome Measures

incidences of unplanned hospital admission; duration of PACU stay

Full Information

NCT ID

NCT00835965

First Posted

February 3, 2009

Last Updated

February 3, 2009

Sponsor

Main Line Health

Collaborators

Merck Sharp & Dohme LLC, Drexel University College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00835965

Brief Title

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

Official Title

A Randomized, Double-Blind Comparison of Oral Aprepitant and Lower Dose Dexamethasone vs Aprepitant Alone for Preventing Postoperative Nausea and Vomiting After Elective Laparoscopic Surgeries

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Main Line Health

Collaborators

Merck Sharp & Dohme LLC, Drexel University College of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

Postoperative Nausea and Vomiting (PONV) is a serious and common (50%-70%) complication of laparoscopic abdominal surgery. PONV is multifactorial, and the treatment is multimodal. Preoperative treatment should target the specific mechanism of PONV to minimize its incidence/consequences to the benefit of the patients. Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P.5 Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Dexamethasone is an inexpensive and effective antiemetic drug with minimal side effects after a single-dose administration. The commonly used minimal effective dose is 8 to 10 mg, but the dose 5 mg is suggested for PONV in patients undergoing laparoscopic surgeries. Based on the literature review, occurrence of PONV does not significantly differ at dosing of Dexamethasone equal or higher than 4 mg. This study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant and dexamethasone or aprepitant alone preoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea, Vomiting

Keywords

Laparoscopic, Surgery, Postoperative, Nausea, Vomiting, Aprepitant, Dexamethasone, Postoperative Nausea, Postoperative Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Description

Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

EMEND

Intervention Description

Dexamethasone 5 mg administered intravenously following endotracheal intubation

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Other Intervention Name(s)

EMEND

Intervention Description

Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Intervention Type

Drug

Intervention Name(s)

Placebo Dexamethasone

Primary Outcome Measure Information:

Title

the incidences of nausea, vomiting, need for rescue medication

Time Frame

1 hour, 2 hours, 24 hours after surgery

Secondary Outcome Measure Information:

Title

incidences of unplanned hospital admission; duration of PACU stay

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dmitri Chamchad, MD

Phone

610-645-6866

chamchad@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mikhail Medved, PhD

Phone

610-645-6866

MedvedM@MLHS.ORG

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dmitri Chamchad, MD

Organizational Affiliation

Lankenau Hospital, Lankenau Institute for Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lankenau Hospital

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

12. IPD Sharing Statement

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

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