PONV Clinical Trial
— PONVOfficial title:
Randomized Double Blind Study to Evaluate the Efficacy of IV Palo w/ IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed Post-Operative Nausea/Vomiting in Subj Undergoing Laparoscopic Surgeries w/a High Emetogenic Risk
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | April 2011 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine | Eisai Inc. |
United States,
Blitz JD, Haile M, Kline R, Franco L, Didehvar S, Pachter HL, Newman E, Bekker A. A randomized double blind study to evaluate efficacy of palonosetron with dexamethasone versus palonosetron alone for prevention of postoperative and postdischarge nausea an — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response Rate | A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia. | Pre-op through 72 hours post emergence from anesthesia | Yes |
Secondary | Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery | Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery. | Pre-op through 96 hours post-op | Yes |
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