NauseaNCT00835965
Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries
A study testing Dexamethasone and Aprepitant in people with Nausea and Vomiting, run by Main Line Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Dexamethasone and Aprepitant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- ASA physical status I-III
- must have at least 2 risk factors for PONV
Who cannot join
- pregnant or breast feeding patients
- antiemetic medication in previous 24 hours
- allergy or other contraindication to study medications
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Dexamethasone, Aprepitant, Placebo Dexamethasone
- Keywords
- Laparoscopic, Surgery, Postoperative, Nausea, Vomiting, Aprepitant, Dexamethasone, Postoperative Nausea, Postoperative Vomiting
- Medical subject headings
- Nausea, Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called EMEND
Dexamethasone 5 mg administered intravenously following endotracheal intubation
AprepitantDrug
Also called EMEND
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Placebo DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting Receives: Drug: Dexamethasone; Drug: Aprepitant |
| Placebo Comparator | Placebo comparator | Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting Receives: Drug: Aprepitant; Drug: Placebo Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidences of nausea, vomiting, need for rescue medication
Measured: 1 hour, 2 hours, 24 hours after surgery
Secondary outcomes (1)
incidences of unplanned hospital admission; duration of PACU stay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Drexel University College of Medicine
- Investigators
- Dmitri Chamchad, MD, Principal investigator, Lankenau Hospital, Lankenau Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835965
- Sponsor's protocol ID
- Merck-Chamchad-2008
- Other IDs
- Merck #32589
- Status last verified
- Feb 2009
- First submitted
- 3 Feb 2009
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00835965
- Acronym / sponsor ID
- Merck-Chamchad-2008
- Keywords
- Laparoscopic, Surgery, Postoperative, Nausea, Vomiting, Aprepitant, Dexamethasone, Postoperative Nausea, Postoperative Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Drexel University College of Medicine
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (estimated)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: Dexamethasone, Drug: AprepitantPatients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting |
| Placebo Comparator | Placebo comparator | Drug: Aprepitant, Drug: Placebo DexamethasonePatients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years old
- ASA physical status I-III
- must have at least 2 risk factors for PONV
Key exclusion criteria (3 listed)
- pregnant or breast feeding patients
- antiemetic medication in previous 24 hours
- allergy or other contraindication to study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: EMENDDexamethasone 5 mg administered intravenously following endotracheal intubation | Drug | Active Comparator |
| AprepitantAlso: EMENDAprepitant 40mg PO one time at least one hour prior to induction of anesthesia | Drug | Active Comparator, Placebo Comparator |
| Placebo Dexamethasone | Drug | Placebo Comparator |
Primary outcome
the incidences of nausea, vomiting, need for rescue medication
Time frame: 1 hour, 2 hours, 24 hours after surgery
1 secondary outcome
incidences of unplanned hospital admission; duration of PACU stay
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Chamchad, MD principal investigator
Lankenau Hospital, Lankenau Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Aprepitant in people with Nausea and Vomiting, run by Main Line Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitri Chamchad, MD (610-645-6866, chamchad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidences of nausea, vomiting, need for rescue medication (time frame: 1 hour, 2 hours, 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.