Study of Nicotine for the Prevention of PONV (NicoPONV)

This study has been terminated.
(Unexpected difficult recruitment. Study drug expired)
Information provided by:
University Hospital, Geneva Identifier:
First received: November 2, 2007
Last updated: September 28, 2009
Last verified: September 2009
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00553709

Division of Anesthesiology, Geneva University Hospitals
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
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 Identifier: NCT00553709     History of Changes
Other Study ID Numbers: 2006DR3327  APSIC 04-010 
Study First Received: November 2, 2007
Last Updated: September 28, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 02, 2016