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

Main Line Health

Status: Unknown

Conditions: Vomiting; Nausea

Treatments: Drug: Dexamethasone; Drug: Aprepitant; Drug: Placebo Dexamethasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00835965

Merck #32589

Merck-Chamchad-2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Active Comparator

Active Comparator group

Description:

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

Treatment:

Drug: Aprepitant

Drug: Dexamethasone

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Dexamethasone

Drug: Aprepitant