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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00835965
• Other study ID #: Merck-Chamchad-2008
• Secondary ID: Merck #32589
• Status: Unknown status
• Phase: N/A
• First received: February 3, 2009
• Last updated: February 3, 2009
• Start date: February 2009

Study information

• Verified date: February 2009
• Source: Main Line Health
• Contact: Dmitri Chamchad, MD
• Phone: 610-645-6866
• Email: chamchad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone
Dexamethasone 5 mg administered intravenously following endotracheal intubation
• Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
• Placebo Dexamethasone

Locations

Country	Name	City	State
United States	Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Main Line Health	Drexel University College of Medicine, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidences of nausea, vomiting, need for rescue medication		1 hour, 2 hours, 24 hours after surgery
Secondary	incidences of unplanned hospital admission; duration of PACU stay		24 hours