Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant + Dexamethasone; Ondansetron + Dexamethasone
Intervention description: Aprepitant 40 mg + Dexamethasone 10 mg; Ondansetron 4 mg + Dexamethasone 10 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PONV; nausea; emesis; antiemetics; aprepitant; ondansetron; dexamethasone

Summary:

      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.
    

Eligibility criteria:

        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.