Does Pregabalin reduce preoperative anxiety: a placebo controlled study - Study of Pregabali
- Conditions
- Patients should receive Pregabalin or placebo as premedication one hour before ambulatory elective surgery. After this they have to assess their anxiety and pain with Visual Analog Scale (VAS) for anxiety and pain und Amsterdam Preoperative Anxiety and Informtion Scale(APAIS)
- Registration Number
- EUCTR2006-002890-31-AT
- Lead Sponsor
- Dept. of Anaesthesia, Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
ASA 1 - 2, age between 18 and 60, minor ambulatory orthopedic surgery under general anaesthesia, female and male
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
Exclusion Criteria
relevant cardiovascular, renal and hepatic deseases, epilepsy, sleeping apnea, pregnancy, containdications to pregabalin, body mass index more than 25
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We would like to test that a single oral pregabalin dose, given one hour before anesthesia, has an anxiolytic effect in patients undergoing minor orthopedic surgery under general anesthesia. ;Secondary Objective: We would like to show that patients receiving pregabalin need less narcotics and less postoperative pain therapy than without pregabalin.;Primary end point(s): APAIS(Amsterdam Preoperative Anxiety and Information Score)
- Secondary Outcome Measures
Name Time Method