Study of Nicotine for the Prevention of PONV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

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

Placebo patch 10 cm2

Group Type PLACEBO_COMPARATOR

Nicotine

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No