Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries
NCT ID: NCT00835965
Last Updated: 2009-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
NCT00734929
Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients
NCT00738621
Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery
NCT00659945
Prevention of Nausea and Vomiting in Patients After Surgery
NCT02021851
The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
NCT01897337
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Comparator
Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting
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 Comparator
Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting
Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Placebo Dexamethasone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ASA physical status I-III
* must have at least 2 risk factors for PONV
Exclusion Criteria
* antiemetic medication in previous 24 hours
* allergy or other contraindication to study medications
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Drexel University College of Medicine
OTHER
Main Line Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Main Line Health System, Lankenau Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dmitri Chamchad, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Hospital, Lankenau Institute for Medical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Merck #32589
Identifier Type: -
Identifier Source: secondary_id
Merck-Chamchad-2008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.