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The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron 4mg Pre-emergence | Placebo Comparator |
| |
| Ondansetron 8mg Pre-emergence | Experimental |
| |
| Ondansetron Pre-Incision and Pre-emergence | Experimental | 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron 4 MG | Drug | dose as per arm selection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Scale | Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea | average of 4 hours in PACU and POD1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Episodes of Vomiting in the PACU | Number of participants with episodes of vomiting in the Post Anesthesia Care Unit | average of 4 hours |
| Number of Participants With Symptoms on POD 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Katz, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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165 patients assessed for eligibility 141 patients were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Ondansetron 4mg Pre-emergence | Ondansetron 4 MG Pre-emergence |
| FG001 | Ondansetron 8mg Pre-emergence | Ondansetron 8mg Pre-emergence |
| FG002 | Ondansetron Pre-Incision and Pre-emergence | 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ondansetron 4mg Pre-emergence | Ondansetron 4 MG Pre-emergence |
| BG001 | Ondansetron 8mg Pre-emergence | Ondansetron 8mg Pre-emergence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Nausea Scale | Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea | only those participants with nausea completed the nausea scale | Posted | Mean | Inter-Quartile Range | score on a scale | average of 4 hours in PACU and POD1 |
|
1 day
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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 | Ondansetron 4mg Pre-emergence | Ondansetron 4 MG Pre-emergence | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Katz | Icahn School of Medicine at Mount Sinai | 212-241-7475 | Daniel.Katz@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2017 | Jun 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
| Ondansetron 8mg | Drug | dose as per arm selection |
|
Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
| Day 1 |
| Number of Participants Who Needed Rescue Anti-emetics | Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU | average of 4 hours |
| Total Anesthesia Time | intraoperative, up to 3.5 hours |
| BG002 | Ondansetron Pre-Incision and Pre-emergence | 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ASA Class | American Society of Anesthesiologist
| Median | Full Range | units on a scale |
|
| BMI | Body Mass Index | Median | Full Range | kg/m^2 |
|
| History of PONV | Post-operative nausea and vomiting | Count of Participants | Participants |
|
| History of Vertigo | Count of Participants | Participants |
|
| History of Motion Sickness | Count of Participants | Participants |
|
| Current Smoker | Count of Participants | Participants |
|
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence |
|
|
| Secondary | Number of Participants With Episodes of Vomiting in the PACU | Number of participants with episodes of vomiting in the Post Anesthesia Care Unit | Posted | Count of Participants | Participants | average of 4 hours |
|
|
|
| Secondary | Number of Participants With Symptoms on POD 1 | Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Number of Participants Who Needed Rescue Anti-emetics | Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU | Posted | Count of Participants | Participants | average of 4 hours |
|
|
|
| Secondary | Total Anesthesia Time | Posted | Mean | Full Range | minutes | intraoperative, up to 3.5 hours |
|
|
|
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Ondansetron 8mg Pre-emergence | Ondansetron 8mg Pre-emergence | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | Ondansetron Pre-Incision and Pre-emergence | 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence | 0 | 43 | 0 | 43 | 0 | 43 |
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| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Male |
|
| Title | Measurements |
|---|---|
|
| Headache |
|