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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00835965
Enrollment
50
Registered
2009-02-04
Start date
2009-02-28
Completion date
Unknown
Last updated
2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

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

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.

Interventions

DRUGDexamethasone

Dexamethasone 5 mg administered intravenously following endotracheal intubation

DRUGAprepitant

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

DRUGPlacebo Dexamethasone

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Drexel University College of Medicine
CollaboratorOTHER
Main Line Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the incidences of nausea, vomiting, need for rescue medication1 hour, 2 hours, 24 hours after surgery

Secondary

MeasureTime frame
incidences of unplanned hospital admission; duration of PACU stay24 hours

Countries

United States

Contacts

Primary ContactDmitri Chamchad, MD
chamchad@hotmail.com610-645-6866
Backup ContactMikhail Medved, PhD
MedvedM@MLHS.ORG610-645-6866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026