” A comparative double-blind placebo-controlled study between alizapride and ondansetron for the prevention of postoperative nausea and vomiting.”
Phase 1
- Conditions
- Prevention of post-operative nausea and vomiting.
- Registration Number
- EUCTR2008-004789-20-BE
- Lead Sponsor
- ZLEUVE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 520
Inclusion Criteria
- ASA 1 and 2
- planned laparoscopic gynaecological surgery
- cooperative patients
- signed informed consent
- female patients over 18 years old
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- ASA 3 and 4
- non-cooperative patients
- allergy to alizapride or ondansetron
- refusal of the patient
- Parkinson's disease
- pregnancy
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