Study of Nicotine for the Prevention of PONV (NicoPONV)

University Hospitals (UH)

Status and phase: Terminated; Phase 2

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT00553709

APSIC 04-010

2006DR3327

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Nicotine patch

Experimental group

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)

Treatment:

Drug: Nicotine

Placebo patch

Placebo Comparator group

Description:

Placebo patch 10 cm2

Treatment:

Drug: Nicotine