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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:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00553709
First received: November 2, 2007
Last updated: September 28, 2009
Last verified: September 2009
History of Changes
  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
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:

U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Geneva
ClinicalTrials.gov 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:
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
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 19, 2013