Nausea and Vomiting, PostoperativePhase 4PDNVNCT00878228
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
A Phase 4 study testing Ondansetron in people with Nausea and Vomiting, Postoperative, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery
- Planned use of neuraxial anesthesia
- Ability to follow study protocol
- Willing to complete daily diary and be interviewed daily for three days after discharge
Who cannot join
- Patients younger than 18 years old and older than 65
- Patients unable to undergo a spinal or epidural anesthetic
- Having nausea or vomiting within 24 hours of the surgery
- Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan)
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Hypersensitivity and/or allergy to ondansetron
Show all 9Show fewer
- Intraoperative use of any volatile anesthetic
- Contraindication to a short course of NSAIDs (renal failure, intolerance)
- Allergy or intolerance to Vicodin
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Ondansetron, Placebo
- 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.
OndansetronDrug
Also called Zofran
The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.
PlaceboDrug
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). Receives: Drug: Ondansetron |
| Control Group | Placebo comparator | The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nausea
Percentage of participants with nausea
Measured: Postdischarge Day 1
Secondary outcomes (2)
Severity of Nausea
Percentage of participants reporting moderate or severe nausea in the first 24 hours
Measured: Postdischarge Day 1
Impact of Nausea and Vomiting on Quality of Life
Percentage of participants whose quality of life was impacted by nausea and vomiting
Measured: Postdischarge Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionFeb 2010
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques YaDeau, MD, PhD, Principal investigator, Hosptial for Special Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878228
- Sponsor's protocol ID
- 29015
- Acronym
- PDNV
- Status last verified
- Jan 2013
- First submitted
- 7 Apr 2009
- Last updated
- 31 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078.
PubMed 9257427Pan PH, Lee SC, Harris LC. Antiemetic prophylaxis for postdischarge nausea and vomiting and impact on functional quality of living during recovery in patients with high emetic risks: a prospective, randomized, double-blind comparison of two prophylactic antiemetic regimens. Anesth Analg. 2008 Aug;107(2):429-38. doi: 10.1213/ane.0b013e318172f992.
PubMed 18633020Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.
PubMed 18042859Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
PubMed 15190136White PF, O'Hara JF, Roberson CR, Wender RH, Candiotti KA; POST-OP Study Group. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008 Aug;107(2):452-8. doi: 10.1213/ane.0b013e31817b842c.
PubMed 18633023White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63. doi: 10.1213/ane.0b013e31817aa6e4.
PubMed 18633024Pavlin DJ, Chen C, Penaloza DA, Polissar NL, Buckley FP. Pain as a factor complicating recovery and discharge after ambulatory surgery. Anesth Analg. 2002 Sep;95(3):627-34, table of contents. doi: 10.1097/00000539-200209000-00025.
PubMed 12198050
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT00878228
- Acronym / sponsor ID
- PDNV / 29015
- Conditions
- Nausea and Vomiting, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Posted 28 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: OndansetronThe study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). |
| Control Group | Placebo comparator | Drug: PlaceboThe control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery
- Planned use of neuraxial anesthesia
- Ability to follow study protocol
- Willing to complete daily diary and be interviewed daily for three days after discharge
Key exclusion criteria (9 listed)
- Patients younger than 18 years old and older than 65
- Patients unable to undergo a spinal or epidural anesthetic
- Having nausea or vomiting within 24 hours of the surgery
- Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan)
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
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 |
|---|---|---|
| OndansetronAlso: ZofranThe study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos. | Drug | Study Group |
| PlaceboThe control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication. | Drug | Control Group |
Primary outcome
Incidence of Nausea
Time frame: Postdischarge Day 1
Percentage of participants with nausea
2 secondary outcomes
Severity of Nausea
Time frame: Postdischarge Day 1
Impact of Nausea and Vomiting on Quality of Life
Time frame: Postdischarge Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9257427Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078.
- Background: PubMed 18633020Pan PH, Lee SC, Harris LC. Antiemetic prophylaxis for postdischarge nausea and vomiting and impact on functional quality of living during recovery in patients with high emetic risks: a prospective, randomized, double-blind comparison of two prophylactic antiemetic regimens. Anesth Analg. 2008 Aug;107(2):429-38. doi: 10.1213/ane.0b013e318172f992.
- Background: PubMed 18042859Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.
- Background: PubMed 15190136Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
- Background: PubMed 18633023White PF, O'Hara JF, Roberson CR, Wender RH, Candiotti KA; POST-OP Study Group. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008 Aug;107(2):452-8. doi: 10.1213/ane.0b013e31817b842c.
- Background: PubMed 18633024White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63. doi: 10.1213/ane.0b013e31817aa6e4.
- Background: PubMed 12198050Pavlin DJ, Chen C, Penaloza DA, Polissar NL, Buckley FP. Pain as a factor complicating recovery and discharge after ambulatory surgery. Anesth Analg. 2002 Sep;95(3):627-34, table of contents. doi: 10.1097/00000539-200209000-00025.
- This is the link to the Hospital for Special Surgery home website.Link provided by the sponsor.
Related trials for Nausea and Vomiting, Postoperative
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Jacques YaDeau, MD, PhD principal investigator
Hosptial for Special Surgery
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 Ondansetron in people with Nausea and Vomiting, Postoperative, run by Hospital for Special Surgery, New York 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 4 inclusion and 9 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 31 Jan 2013. 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.
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?
Yes. Results are posted in the registry (first posted 28 Aug 2012). 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?
Incidence of Nausea (time frame: Postdischarge Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878228, which also lists 7 linked publications.
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 31 Jan 2013.