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
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Drexel University College of Medicine
Information provided by:
Main Line Health
ClinicalTrials.gov Identifier:
NCT00835965
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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
Nausea
Vomiting
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835965

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

Locations
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
Investigators
Principal Investigator: Dmitri Chamchad, MD Lankenau Hospital, Lankenau Institute for Medical Research
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on April 17, 2014