Trial · NCT01474915
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
NCT01474915, Phase 4, Completed, Sergio Bergese; results first posted 2013-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting. Trials, record NCT01474915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01474915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
- NCT number
- NCT01474915
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 122 participants, actual
- Lead sponsor
- Sergio Bergese
- Conditions
- Postoperative Nausea and Vomiting (PONV), Nausea
- Interventions
- Aprepitant, Ondansetron, Promethazine, Dexamethasone
- First posted
- 2011-11-18
- Last updated
- 2013-12-03
- Results first posted
- 2013-12-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia | 24 hours post operatively | To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia. \- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia. Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia. Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia. |
| Secondary | Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale | 24 hours post-operatively | To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia. \- Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery. Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia | 24 hours post operatively | Number of patients with Complete Control | participants | NUMBER |
| SECONDARY | Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale | 24 hours post-operatively | Severity of nausea and vomiting | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia | Aprepitant | Complete Control | 38 | participants | |
| Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia | Ondansetron | Complete Control | 41 | participants | |
| Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia | Aprepitant | Complete Response | 30 | participants | |
| Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia | Ondansetron | Complete Response | 30 | participants | |
| Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale | Aprepitant | Nausea episodes | 1 | Full Range 1 to 2 | units on a scale |
| Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale | Ondansetron | Nausea episodes | 1 | Full Range 1 to 2 | units on a scale |
| Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale | Aprepitant | Vomiting episodes | 1.5 | Full Range 1 to 2 | units on a scale |
| Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale | Ondansetron | Vomiting episodes | 1.5 | Full Range 1 to 3 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aprepitant | 60 | |
| Overall Study | STARTED | Ondansetron | 61 | |
| Overall Study | COMPLETED | Aprepitant | 50 | |
| Overall Study | COMPLETED | Ondansetron | 51 | |
| Overall Study | NOT COMPLETED | Aprepitant | 10 | |
| Overall Study | NOT COMPLETED | Ondansetron | 10 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Fever | General disorders | Aprepitant | 0 | 60 | 0 |
| serious | Fever | General disorders | Ondansetron | 1 | 61 | 1 |
| serious | Deep Vein Thrombosis | Vascular disorders | Aprepitant | 0 | 60 | 0 |
| serious | Deep Vein Thrombosis | Vascular disorders | Ondansetron | 1 | 61 | 1 |
| serious | Cerebrovascular Hematoma | Nervous system disorders | Aprepitant | 2 | 60 | 2 |
| serious | Cerebrovascular Hematoma | Nervous system disorders | Ondansetron | 0 | 61 | 0 |
| serious | Cerebrospinal fluid leak | Nervous system disorders | Aprepitant | 0 | 60 | 0 |
| serious | Cerebrospinal fluid leak | Nervous system disorders | Ondansetron | 1 | 61 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aprepitant | ||
| Total, all-cause mortality | Ondansetron | ||
| Total, other adverse events | Aprepitant | 0 | 60 |
| Total, other adverse events | Ondansetron | 0 | 61 |
| Total, serious adverse events | Aprepitant | 2 | 60 |
| Total, serious adverse events | Ondansetron | 3 | 61 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aprepitant vs Ondansetron: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01474915
GET https://conductscience.org/api/trials/v1/NCT01474915/registered