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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Main Line Health.
Recruitment status was  Not yet recruiting
Merck Sharp & Dohme Corp.
Drexel University College of Medicine
Information provided by:
Main Line Health
ClinicalTrials.gov Identifier:
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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.

Condition Intervention
Drug: Dexamethasone
Drug: Aprepitant
Drug: Placebo Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • the incidences of nausea, vomiting, need for rescue medication [ Time Frame: 1 hour, 2 hours, 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidences of unplanned hospital admission; duration of PACU stay [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator
Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting
Drug: Dexamethasone
Dexamethasone 5 mg administered intravenously following endotracheal intubation
Other Name: EMEND
Drug: Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Other Name: EMEND
Placebo Comparator: Placebo Comparator
Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting
Drug: Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Other Name: EMEND
Drug: Placebo Dexamethasone

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835965

Contact: Dmitri Chamchad, MD 610-645-6866 chamchad@hotmail.com
Contact: Mikhail Medved, PhD 610-645-6866 MedvedM@MLHS.ORG

United States, Pennsylvania
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Main Line Health
Merck Sharp & Dohme Corp.
Drexel University College of Medicine
Principal Investigator: Dmitri Chamchad, MD Lankenau Hospital, Lankenau Institute for Medical Research
  More Information

Responsible Party: Dmitri Chamchad, MD, Main Line Health System, Lankenau Hospital
ClinicalTrials.gov Identifier: NCT00835965     History of Changes
Other Study ID Numbers: Merck-Chamchad-2008  Merck #32589 
Study First Received: February 3, 2009
Last Updated: February 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Main Line Health:
Postoperative Nausea, Postoperative Vomiting

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016