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Study of Nicotine for the Prevention of PONV (NicoPONV)

Primary Purpose

Postoperative Nausea and Vomiting

Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Nicotine
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring nausea, vomiting, retching, emesis, surgery, anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Anesthesiology, Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotine patch

Placebo patch

Arm Description

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 patch 10 cm2

Outcomes

Primary Outcome Measures

Prevention of PONV

Secondary Outcome Measures

Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.

Full Information

First Posted
November 2, 2007
Last Updated
September 28, 2009
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00553709
Brief Title
Study of Nicotine for the Prevention of PONV
Acronym
NicoPONV
Official Title
The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
Unexpected difficult recruitment. Study drug expired
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
nausea, vomiting, retching, emesis, surgery, anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nicotine patch
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Arm Description
Placebo patch 10 cm2
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Prevention of PONV
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin R Tramèr, MD, DPhil
Organizational Affiliation
University Hospital, Geneva
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel Bertrand, PhD
Organizational Affiliation
Medical Faculty, Geneva University
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Anesthesiology, Geneva University Hospitals
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland

12. IPD Sharing Statement

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Study of Nicotine for the Prevention of PONV

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