Phase 4
N=121
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
Postoperative Nausea and Vomiting (PONV) · Nausea
Bottom Line
View on ClinicalTrials.gov: NCT01474915 ↗Enrolled (actual)
121
Serious AEs
4.1%
Results posted
Dec 2013
Primary outcome: Primary: Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia — 38; 41; 30; 30 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aprepitant (Drug); Ondansetron (Drug); Promethazine (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sergio Bergese
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia |
38; 41; 30; 30 | — |
| SECONDARY Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale |
1; 1; 1.5; 1.5 | — |
Summary
This study is being done to determine the efficacies of two preventative drug combinations for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this study is to compare the efficacy of using aprepitant instead of ondansetron in combination with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By completing this comparison study investigators will determine the most efficacious drug combination which will allow us to enhance the overall comfort and satisfaction of neurosurgical patients in the immediate postoperative period.
Eligibility Criteria
Inclusion Criteria
- Adult patients
- 18 to 85 years of age
- Scheduled for neurosurgery requiring opening of the cranium and dura at Ohio State University Medical Center and who consent in writing to participate in this study are eligible.
Exclusion Criteria
- Patients will be excluded from this study if they are
- prisoners
- pregnant women
- mentally ill
- under the age of 18 or over the age of 85
- American Society of Anesthesiologist (ASA) classification V
- alcohol or drug abusers
- have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50 mmHg.
Data sourced from ClinicalTrials.gov (NCT01474915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.