Prospective randomised double blind comparative study of cinnarizine versus placebo as prophylactic anti-travel sickness therapy in patients undergoing dy-case gynaecological surgery. - Cinnarizine Study
- Conditions
- Post operative nausea and vomiting and motion sickness
- Registration Number
- EUCTR2004-002180-24-GB
- Lead Sponsor
- Swindon & Marlborough NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 272
1. Female patients
2. Undergoing day case gynaecological surgery
3. Aged 18-60 years
4. ASA 1 & 2
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) no
F.1.3.1 Number of subjects for this age range
1. Those who are unable to give informed consent.
2. Patients with gastrointestinal disease.
3. Patients with hepatic or renal disease.
4. Pregnant or lactating patients.
5. Those patients with known or suspected adverse reactions to the study drugs.
6. Patients undergoing therapeutic termination of pregnancy.
7. Patients undergoing surgery for miscarriage.
8. Obese patients (BMI>30)
9. Patients suffering from pre-operative nausea or vomiting
10. Patients receiving current oral or intramuscular steroid therapy.
11. Patients suffering severe acute anxiety reactions.
12. Patients receiving other anti-emetic drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the clinical efficacy of a single post-operative dose of cinnarizine in the prevention of post-operative nausea and vomiting associated with the journey home after day-case gynaecological surgery.;Secondary Objective: ;Primary end point(s): Nausea, Retching and Vomiting.<br><br>
- Secondary Outcome Measures
Name Time Method