Study of Nicotine for the Prevention of PONV (NicoPONV)

This study has been terminated.
(Unexpected difficult recruitment. Study drug expired)
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00553709
First received: November 2, 2007
Last updated: September 28, 2009
Last verified: September 2009

November 2, 2007
September 28, 2009
October 2007
August 2009   (final data collection date for primary outcome measure)
Prevention of PONV [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
Prevention of PONV [ Time Frame: 48 hours postoperatively ]
Complete list of historical versions of study NCT00553709 on ClinicalTrials.gov Archive Site
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction. [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: Yes ]
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction. [ Time Frame: 48 hours postoperatively ]
Not Provided
Not Provided
 
Study of Nicotine for the Prevention of PONV
The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers

The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
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)
  • 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)
    Intervention: Drug: Nicotine
  • Placebo Comparator: Placebo patch
    Placebo patch 10 cm2
    Intervention: Drug: Nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00553709
2006DR3327, APSIC 04-010
Yes
University Hospital, Geneva
University Hospital, Geneva
Not Provided
Study Chair: Martin R Tramèr, MD, DPhil University Hospital, Geneva
Study Chair: Daniel Bertrand, PhD Medical Faculty, Geneva University
University Hospital, Geneva
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP