Postoperative Nausea and VomitingNCT02597907
Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
A study testing aprepitant, palonosetron and Ramosetron in people with Postoperative Nausea and Vomiting, run by Kyungpook National University Hospital.
Trial summary
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- aprepitant, palonosetron and Ramosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non smoking, female patients, scheduled for laparoscopic cholecystectomy
Who cannot join
- Patients with gastrointestinal disorder,
- Patients with allergies to any study medication,
- Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery
About this study
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
Read the detailed description
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
Study is performed during 24 hours after surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- aprepitant, palonosetron, Ramosetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
aprepitant 80 mg is given to all patients before surgery
palonosetronDrug
palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
RamosetronDrug
ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| aprepitant plus palonosetron | Experimental | aprepitant 80 mg palonosetron 0.075 mg Receives: Drug: aprepitant; Drug: palonosetron |
| aprepitant plus ramosetron | Active comparator | aprepitant 80 mg ramosetron 0.3 mg Receives: Drug: aprepitant; Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and vomiting during 24 hours postoperatively
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 posted5 Nov 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597907
- Sponsor's protocol ID
- KNUH 2014-05-016
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2015
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
- ClinicalTrials.gov ID
- NCT02597907
- Acronym / sponsor ID
- KNUH 2014-05-016
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
Detailed description
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
Study is performed during 24 hours after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aprepitant plus palonosetron | Experimental | Drug: aprepitant, Drug: palonosetronaprepitant 80 mg palonosetron 0.075 mg |
| aprepitant plus ramosetron | Active comparator | Drug: aprepitant, Drug: Ramosetronaprepitant 80 mg ramosetron 0.3 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non smoking, female patients, scheduled for laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- Patients with gastrointestinal disorder,
- Patients with allergies to any study medication,
- Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery
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 |
|---|---|---|
| aprepitantaprepitant 80 mg is given to all patients before surgery | Drug | aprepitant plus palonosetron, aprepitant plus ramosetron |
| palonosetronpalonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia | Drug | aprepitant plus palonosetron |
| Ramosetronramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia | Drug | aprepitant plus ramosetron |
Primary outcome
The Incidence of Postoperative Nausea and Vomiting
Time frame: 24 hours
The incidence of postoperative nausea and vomiting during 24 hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aprepitant, palonosetron and Ramosetron in people with Postoperative Nausea and Vomiting, run by Kyungpook National University Hospital.
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 1 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: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Postoperative Nausea and Vomiting (time frame: 24 hours). 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 25 Apr 2017.