Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Eisai Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Palonosetron

Criteria

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