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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). |
|
| Control Group | Placebo Comparator | The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea | Percentage of participants with nausea | Postdischarge Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Nausea | Percentage of participants reporting moderate or severe nausea in the first 24 hours | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques YaDeau, MD, PhD | Hosptial for Special Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9257427 | Background | 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. | |
| 18633020 |
| Label | URL |
|---|---|
| This is the link to the Hospital for Special Surgery home website. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). |
| FG001 | Control Group | The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). |
| BG001 | Control Group | The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | 98 patients were enrolled in the study, but 22 were excluded for various reasons. The remaining 76 patients were analyzed for the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Nausea | Percentage of participants with nausea | Posted | Number | percentage of participants | Postdischarge Day 1 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Kim | Hospital for Special Surgery | 212-606-1206 | KimD@hss.edu |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Placebo | Drug | 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. |
|
| Postdischarge Day 1 |
| Pan 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. |
| 18042859 | Background | Gan 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. |
| 15190136 | Background | Apfel 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. |
| 18633023 | Background | White 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. |
| 18633024 | Background | White 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. |
| 12198050 | Background | Pavlin 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 98 patients were enrolled in the study, but 22 were excluded for various reasons. The remaining 76 patients were analyzed for the study. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Severity of Nausea | Percentage of participants reporting moderate or severe nausea in the first 24 hours | Posted | Number | percentage of participants | Postdischarge Day 1 |
|
|
|
| Secondary | Impact of Nausea and Vomiting on Quality of Life | Percentage of participants whose quality of life was impacted by nausea and vomiting | Posted | Number | percentage of participants | Postdischarge Day 1 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Control Group | The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). | 0 | 49 | 0 | 49 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |