Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV (PONV)
|ClinicalTrials.gov Identifier: NCT00952133|
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : March 31, 2014
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|PONV||Drug: Palonosetron only Drug: Palonosetron with Dexamethasone||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official 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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||April 2011|
Experimental: Palonosetron with Dexamethasone
Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
Drug: Palonosetron with Dexamethasone
Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.
Placebo Comparator: Palonosetron only
Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
Drug: Palonosetron only
The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.
- Complete Response Rate [ Time Frame: Pre-op through 72 hours post emergence from anesthesia ]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.
- Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery [ Time Frame: Pre-op through 96 hours post-op ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952133
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Jeanna Blitz, MD||NYU School of Medicine|