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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00553709
Other study ID # 2006DR3327
Secondary ID APSIC 04-010
Status Terminated
Phase Phase 2
First received November 2, 2007
Last updated September 28, 2009
Start date October 2007
Est. completion date August 2009

Study information

Verified date September 2009
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Switzerland Division of Anesthesiology, Geneva University Hospitals Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevention of PONV 48 hours postoperatively No
Secondary Adverse effects that may be related to the nicotine patch, for instance, local skin reaction. 48 hours postoperatively Yes
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