NCT00553709

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

November 2, 2007

Last Update Submit

September 28, 2009

Conditions

Postoperative Nausea and Vomiting

Keywords

nauseavomitingretchingemesissurgeryanesthesia

Outcome Measures

Primary Outcomes (1)

  • Prevention of PONV

    48 hours postoperatively

Secondary Outcomes (1)

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

    48 hours postoperatively

Study Arms (2)

Nicotine patch

EXPERIMENTAL

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

Placebo patch

PLACEBO COMPARATOR

Placebo patch 10 cm2

Drug: Nicotine

Interventions

NicotineDRUG

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)

Nicotine patchPlacebo patch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers (cigarette, pipe, cigar)
  • Patients undergoing nicotine replacement therapy
  • Prolonged postoperative intubation
  • Postoperative nasogastric tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Anesthesiology, Geneva University Hospitals

Geneva, Canton of Geneva, CH-1211, Switzerland

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Martin R Tramèr, MD, DPhil

    University Hospital, Geneva

    STUDY CHAIR

  • Daniel Bertrand, PhD

    Medical Faculty, Geneva University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations

CH(1)