Clinical trial NCT00835965: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Laparoscopic
Surgery
Postoperative
Nausea
Vomiting
Aprepitant
Dexamethasone
Postoperative Nausea, Postoperative Vomiting
Lead sponsor: Main Line Health
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Drexel University College of Medicine
First posted: 2009-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: the incidences of nausea, vomiting, need for rescue medication
timeFrame: 1 hour, 2 hours, 24 hours after surgery
Secondary outcomes:
measure: incidences of unplanned hospital admission; duration of PACU stay
timeFrame: 24 hours
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
Study officials:
affiliation: Lankenau Hospital, Lankenau Institute for Medical Research
name: Dmitri Chamchad, MD
role: PRINCIPAL_INVESTIGATOR
References: