Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)
This study has been withdrawn prior to enrollment.
(The study is not feasible with the number of subjects needed to complete it.)
Sponsor:
Ochsner Health System
Information provided by (Responsible Party):
Stuart Hart, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT00775749
First received: October 17, 2008
Last updated: October 25, 2011
Last verified: October 2011
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Purpose
The purpose of this study is to see if the nicotine patch reduces post operative nausea and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.
| Condition | Intervention |
|---|---|
|
Postoperative Nausea and Vomiting |
Drug: transdermal nicotine patch Drug: placebo patch |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Transdermal Nicotine in Female Patients at High Risk for PONV |
Resource links provided by NLM:
Further study details as provided by Ochsner Health System:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 560 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Detailed Description:
There are certain known risk factors for post-operative nausea and/or vomiting: the use of opioids during surgery, female gender, laparoscopic surgery, gynecologic surgery, strabismus repair, the use of a general anesthetic, obesity, and non-smoker. Patients with four or more of these risk factors have an 80% occurrence rate of post-operative nausea and/or vomiting and are classified as "high risk". It has been shown that those who use tobacco have about a 50% reduction in post-operative nausea and/or vomiting.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- age 18-65
- female
- health patient or acute illness
- undergoing outpatient-type general surgery, especially those associated with increased incidence of post-operative nausea and/or vomiting such as gynecological procedures
- undergoing general anesthesia for the surgery
- receiving opioids during surgery
- non-smokers
Exclusion Criteria:
- history of any heart condition
- history of uncontrolled hypertension, or presence of any condition that could be made drastically worse by an increase in blood pressure
- history of an aneurysm
- active tobacco use within the past five years
- works or lives in the presence of cigarette smoke
- pregnant
- mentally ill
- prisoners
- history of allergic reaction to nicotine or to adhesive patches
- history of allergic reaction to propofol, versed, fentanyl, zofran, decadron, and reglan
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775749
Locations
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
Sponsors and Collaborators
Ochsner Health System
Investigators
| Principal Investigator: | Stuart R Hart, M.D. | Ochsner Health Systems |
| Study Director: | Heather S Porter | Ochsner Health Systems |
More Information
Additional Information:
Publications:
| Responsible Party: | Stuart Hart, Director of Obstetric Anesthesiology, Ochsner Health System |
| ClinicalTrials.gov Identifier: | NCT00775749 History of Changes |
| Other Study ID Numbers: | PONV |
| Study First Received: | October 17, 2008 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ochsner Health System:
|
post operative nausea and vomiting gynecological surgery outpatient surgery nicotine patch laparoscopic surgery |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013