NauseaPhase 4NCT01007500
Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
A Phase 4 study testing Dexamethasone and Ondansetron in people with Nausea and Vomiting, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- What is being tested?
- Dexamethasone and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing video-assisted thoracoscopic surgery
- Age 20-75
- American Society of Anesthesiologists physical status classification I or II
Who cannot join
- Antiemetic within 24 hrs
- Taking Steroids, Opioids within 1 week
- Active drug or alcohol abuse
- GI motility disorder, severe renal/ hepatic disease.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.
- Being tested
- Dexamethasone, Ondansetron
- Keywords
- Postoperative nausea and vomiting after video-assisted thoracoscopic surgery
- 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
Experimental: Dexamethasone 8 mg IV after induction of anesthesia, Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.
OndansetronDrug
Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.
| Study group | Role | What they receive |
|---|---|---|
| Group Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Group Ondansetron | Active comparator | Not described Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
Measured: within 48 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionSep 2010
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007500
- Sponsor's protocol ID
- 4-2009-0407
- Status last verified
- Dec 2016
- First submitted
- 3 Nov 2009
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT01007500
- Acronym / sponsor ID
- 4-2009-0407
- Keywords
- Postoperative nausea and vomiting after video-assisted thoracoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Nov 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 purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexamethasone | Experimental | Drug: Dexamethasone |
| Group Ondansetron | Active comparator | Drug: Ondansetron |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing video-assisted thoracoscopic surgery
- Age 20-75
- American Society of Anesthesiologists physical status classification I or II
Key exclusion criteria (4 listed)
- Antiemetic within 24 hrs
- Taking Steroids, Opioids within 1 week
- Active drug or alcohol abuse
- GI motility disorder, severe renal/ hepatic disease.
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 |
|---|---|---|
| DexamethasoneExperimental: Dexamethasone 8 mg IV after induction of anesthesia, Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device. | Drug | Group Dexamethasone |
| OndansetronActive comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device. | Drug | Group Ondansetron |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: within 48 hrs after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Ondansetron in people with Nausea and Vomiting, run by Yonsei University at 1 site in South Korea.
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 4 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 30 Dec 2016. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of postoperative nausea and vomiting (time frame: within 48 hrs 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 30 Dec 2016.