Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
NCT ID: NCT01474915
Last Updated: 2013-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2007-06-30
2013-04-30
Brief Summary
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Detailed Description
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The following demographic and preoperative data about each patient in the two groups will be recorded:
Demographic and Preoperative Data Gender Systolic blood pressure, diastolic blood pressure, median blood pressure Age Smoking history PONV History Motion sickness history Surgery Anesthesia modality CPP Race ECG recording Hepatic function Renal function Past reactions to the study drugs
The duration of each surgery (anesthesia time) will be recorded for each patient. Patients will be continuously monitored in the post anesthesia care unit (PACU), surgical intensive care unit (SICU) and the medical floor for a total of 120 hours post operatively. Episodes of nausea, vomiting and administration of rescue therapy for either nausea or vomiting will be recorded and time stamped. In addition, the severity of the nausea or vomiting will be recorded. Nausea will be evaluated by the patient utilizing a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting will be evaluated by the investigator or nursing staff numerically as either 0, no vomiting, 1, mild vomiting, 2, moderate vomiting, or 3, severe vomiting. Rescue therapy for PONV episodes will consist of 4mg ondansetron. After the first 24hrs of starting the triple therapy antiemetic, ECG will be recorded as well as blood drawn for analysis.
Variables Primary Efficacy Variable The percentage of patients with no vomiting over 0-72 hours post operatively across the two treatment groups.
Secondary Efficacy Variables: Proportion of patients with a complete response during delayed (24-120 hours; days 2-5) and overall (0-120 hours; days 1-5) after neurological surgery and general anesthesia.
Proportion of patients with complete control, defined as no emetic episode, no need for rescue medication and no more than mild nausea overall (0-120 hours; days 1-5) after neurological surgery and general anesthesia.
Assess the severity of nausea and vomiting during acute (0-24 hours), delayed (24-120 hours) and overall (0-120 hours) intervals after neurological surgery and general anesthesia.
Assess the time to treatment failure (defined as time to first emetic episode and/or to first use of rescue medication).
Assess the time to first emetic episode.
Assess the time to significant nausea (defined as nausea rated ≥ 4 on a 0 to 10 verbal response scale or nausea that required rescue therapy).
Adverse Reactions to Treatment The incidence of any adverse reaction to treatment in the our two experimental groups will be recorded. In the ondansetron-treated patients (Group I), all cardiovascular, gastrointestinal, hepatic, integumentary and neurologic postoperative adverse events will be recorded and analyzed for cause. For instance, treatment-related diarrhea, headaches, fever, akathisia and acute dystonic reactions will be recorded and analyzed. Similarly, in the aprepitant-patients (Group II) all adverse events related to the digestive, hemic, lymphatic, nervous, cardiovascular and respiratory systems will be recorded and analyzed for cause.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Aprepitant
Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Aprepitant
Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
Promethazine
Subject will receive 25 mg of Promethazine IV around anesthesia induction
Dexamethasone
Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Ondansetron
Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.
Triple therapy
4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV
Ondansetron
Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine
Subject will receive 25 mg of Promethazine IV around anesthesia induction
Dexamethasone
Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Interventions
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Aprepitant
Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
Ondansetron
Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
Promethazine
Subject will receive 25 mg of Promethazine IV around anesthesia induction
Dexamethasone
Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1. prisoners
2. pregnant women
3. mentally ill
4. under the age of 18 or over the age of 85
5. American Society of Anesthesiologist (ASA) classification V
6. alcohol or drug abusers
7. have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50 mmHg.
18 Years
85 Years
ALL
Yes
Sponsors
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Sergio Bergese
OTHER
Responsible Party
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Sergio Bergese
Associate Professor
Principal Investigators
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Sergio D Bergese, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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2007H0053
Identifier Type: -
Identifier Source: org_study_id