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This study has been withdrawn prior to enrollment.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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

ClinicalTrials.gov processed this record on September 16, 2014