Status:
COMPLETED
Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Eisai Inc.
Conditions:
PONV
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
Detailed Description
Post-operative nausea and vomiting (PONV) is a frequent complication of surgery, with considerable medical and economic impact. It is also associated with high levels of patient discomfort and dissati...
Eligibility Criteria
Inclusion
- Has signed an informed consent form
- Have an American Society of Anesthesiologists (ASA) Physical Status Classification of I, II, or III
- Female, 18-55 years old
- surgically sterilized, or
- pre-menopausal, with a negative pregnancy test within 7 days before study medication administration
- Male, 18-55 years old, who has more than 3 risk factors for PONV
- Undergoing outpatient laparoscopic gynecological surgery or laparoscopic abdominal surgery, scheduled for between 1 and 3 hours duration
- Known to have a history of post-operative nausea and vomiting and/or a history of motion sickness
- Has been a non-smoker for at least the previous 12 consecutive months
- Is able and willing to complete a subject diary until the end of the 96 Hour Follow-Up Assessment period
- Will be available to respond to follow-up by study personnel at 72 and 96 hours post emergence from anesthesia
Exclusion
- Has an ASA Physical Status Classification of IV or V
- Is pregnant or breastfeeding
- Has been taking more than 10-15mg of oxycodone, or an equivalent opioid dose, on a regular, daily basis, for more than 3 consecutive days before surgery
- Has received an investigational drug in the precious 30 days or who is schedule to receive any investigational drug during the study period
- Has persistent or recurrent nausea and/or vomiting due to other etiologies, including but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, or brain metastases
- Experienced retching or vomiting or uncontrolled nausea within 48 hours before administration of study drug
- Received medication with known or potential antiemetic activity within 24 hours before receiving study drug. This includes, but is not limited to: phenothiazines, butyrophenones, hydroxyzine, lorazepam, cannabinoids, metoclopramide, corticosteroids (with the exception of topical steroids for skin disorder and inhaled steroids for respiratory disorders), trimethobenzamide, monoamine oxidase inhibitors, lithium, and 5-HT3 receptor antagonists. Subjects who might require one or more of these medications during the 24-hour treatment period, other than as described in this protocol, are also excluded.
- Note: benzodiazepines other than lorazepam are allowed within 24 hours before and during study period, but only when used for indications such as anxiety or to induce sleep.
- Received radiation therapy to abdomen or pelvis in the 7 days prior to receiving study medication and/or will receive radiation therapy to abdomen or pelvis in the evaluation period.
- Has a history of poorly controlled diabetes mellitus
- Has a history of wound dehiscence
- Has had an incidence of necrotizing fasciitis, or any similar infectious process, within the previous 90 days
- Has a know systemic fungal infection, history of tuberculosis, or other mycobacterial infection
- Is immunocompromised - defined as a white blood cell (WBC) count of \<3,000 mm3
- Has any current or past medical condition (e.g., vagotomy) and/or require medication to treat a condition that could confound the evaluation of the data collected in this clinical trail
- Has a known hypersensitivity or contraindication to palonosetron hydrochloride or any another 5-HT3 receptor antagonist, dexamethasone, or any scheduled anesthetic or analgesic agents
- Has a known hypersensitivity to fentanyl and/or ketorolac tromethamine
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00952133
Start Date
July 1 2009
End Date
April 1 2011
Last Update
April 17 2015
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016