Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)
|ClinicalTrials.gov Identifier: NCT00775749|
Recruitment Status : Withdrawn (The study is not feasible with the number of subjects needed to complete it.)
First Posted : October 20, 2008
Last Update Posted : October 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: transdermal nicotine patch Drug: placebo patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Transdermal Nicotine in Female Patients at High Risk for PONV|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||April 2012|
The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours.
Drug: transdermal nicotine patch
The 7 mg transdermal nicotine patch will be applied to the right upper back prior to surgery. It will be covered with an opaque bandage to minimize inadvertent removal and conceal which patch has been placed.
Other Name: Nicoderm CQ Step 3
Placebo Comparator: 2
The placebo patch has no active ingredients and the same inactive ingredients as the nicotine patch. It will be administered the same fashion as the nicotine patch.
Drug: placebo patch
The placebo patch will be applied to the right upper back prior to surgery. It will be covered with an opaque bandage to minimize inadvertent removal and conceal which patch has been placed.
Other Name: Tegaderm patch
- The primary outcome measure is whether the patient experienced post-operative nausea and/or vomiting. [ Time Frame: The outcome measure will be assessed within 24 hours after the application of the patch. ]
- The secondary outcome is to assess how many episodes of post-operative nausea and/or vomiting the patient experiences. [ Time Frame: The outcome measure will be assessed within 24 hours of the application of the patch. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775749
|United States, Louisiana|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|Principal Investigator:||Stuart R Hart, M.D.||Ochsner Health Systems|
|Study Director:||Heather S Porter||Ochsner Health Systems|