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Study of Nicotine for the Prevention of PONV (NicoPONV)

This study has been terminated.
(Unexpected difficult recruitment. Study drug expired)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553709
First Posted: November 5, 2007
Last Update Posted: September 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  Purpose
The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery

Condition Intervention Phase
Postoperative Nausea and Vomiting Drug: Nicotine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Prevention of PONV [ Time Frame: 48 hours postoperatively ]

Secondary Outcome Measures:
  • Adverse effects that may be related to the nicotine patch, for instance, local skin reaction. [ Time Frame: 48 hours postoperatively ]

Estimated Enrollment: 200
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine patch
Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)
Drug: Nicotine
Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)
Placebo Comparator: Placebo patch
Placebo patch 10 cm2
Drug: Nicotine
Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18-80 years)
  • ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
  • Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
  • Consenting to take part in the study will be included.

Exclusion Criteria:

  • Smokers (cigarette, pipe, cigar)
  • Patients undergoing nicotine replacement therapy
  • Prolonged postoperative intubation
  • Postoperative nasogastric tube
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553709


Locations
Switzerland
Division of Anesthesiology, Geneva University Hospitals
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Chair: Martin R Tramèr, MD, DPhil University Hospital, Geneva
Study Chair: Daniel Bertrand, PhD Medical Faculty, Geneva University
  More Information

Responsible Party: University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00553709     History of Changes
Other Study ID Numbers: 2006DR3327
APSIC 04-010
First Submitted: November 2, 2007
First Posted: November 5, 2007
Last Update Posted: September 29, 2009
Last Verified: September 2009

Keywords provided by University Hospital, Geneva:
nausea
vomiting
retching
emesis
surgery
anesthesia

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
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action