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

Not Applicable

• Conditions: Nausea; Vomiting
• Interventions: Drug: Dexamethasone; Drug: Placebo Dexamethasone; Drug: Aprepitant

• Registration Number: NCT00835965
• Lead Sponsor: Main Line Health

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.

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Last Update Submitted: 2009-02-03
• Study First Posted: 2009-02-04
• Last Update Posted: 2009-02-04
• Primary Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo Dexamethasone	Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting
Active Comparator	Dexamethasone	Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting
Active Comparator	Aprepitant	Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting
Placebo Comparator	Aprepitant	Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting

Primary Outcome Measures

Name	Time	Method
the incidences of nausea, vomiting, need for rescue medication	1 hour, 2 hours, 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
incidences of unplanned hospital admission; duration of PACU stay	24 hours

Trial Locations

Locations (1)

Lankenau Hospital; 🇺🇸 Wynnewood, Pennsylvania, United States