Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

Study Overview
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Brief Summary
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We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Official Title
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A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Aprepitant + Dexamethasone
* Drug: Ondansetron + Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient is eligible for inclusion in this study if all of the following criteria apply: Age: 18-75 years of age Surgery: craniotomy under general anesthesia. American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III Language: Fluent in the English language Informed Consent: Written informed consent must be obtained. Exclusion Criteria: A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial: Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results. Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant. Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure. Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential. Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments. Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments. Nausea verbal rating score (VRS): A VRS nausea score > 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia | Drug: Aprepitant + Dexamethasone<br>* Aprepitant 40 mg + Dexamethasone 10 mg<br>|
| Active Comparator: 2<br>Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia | Drug: Ondansetron + Dexamethasone<br>* Ondansetron 4 mg + Dexamethasone 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Emesis | Any vomiting or retching | 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nausea | operative procedure | Post operative procedure (OP) hours (0-2, 24, 48) | 
| Incidence of Vomiting (Post OP) |  | Post OP (0 - 2 hours) | 
| Incidence of Vomiting (24 Hours) | Any vomiting or retching | 24 h | 
| Use of Rescue Antiemetics (Post OP) |  | Post OP (0 - 2 hours) | 
| Use of Rescue Antiemetics (24 Hours) |  | 24 h | 
| Use of Rescue Antiemetics (48 Hours) |  | 48 hour | 
| Number of Participants With a Complete Response Rate | complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics. | 24 hours Post OP, 48 hours Post OP | 
| Average Nausea Score | Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable | Post OP hours 0-2, 24 h, 48 h | 
| Number of Vomiting Episodes |  | 48 hours | 
| Time to First Vomiting |  | 48 h | 
| Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied | Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied) | 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, nausea, emesis, antiemetics, aprepitant, ondansetron, dexamethasone