Prospective randomized double blind trial on the use of Scopoderm patch for control of post-operative nausea and vomitting in patients undergoing gynecologic laparoscopic procedures.
- Conditions
- Post-operative nausea and vomiting in patients undergoing gynecologic laparoscopic procedures.
- Registration Number
- EUCTR2005-005928-13-IS
- Lead Sponsor
- andspitali-University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
Patients scheduled to undergo gynecologic laparoscopic surgery at Landspitali University Hospital will be offered to participate. In order to detect a 25% difference in nausea between tha two groups we project that we will need to enroll 24 patients in each group for a total of 48 patients. This is assuming an alpha of 0.05 and a beta of 0.20.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Nursing and pregnant women, allergy to substances in the patch, narrow angle glaucoma.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method