This is a patient study in patients with a planned operation under general anaesthesie including healthy or merately ill patients (anaesthesia risk classification ASA 1-3). Pain self assessment as a function of sedation by IMP is studied.
Conditions
Interventions
Trade Name: Propofol-Lipuro 1% (10mg/ml)
Product Name: Propofol
Pharmaceutical Form: Intravenous infusion
Sponsors
Department of Anaesthesie, General Intensive Care and Pain Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Painless patients with a planned operation and anaesthesie Consent into generally anaesthesia Consent into the study Completed 18 year of life ASA-Classification 1-3 Availability of a seeing aid in case of a amblyopia Hearing aid in case of a hypakusis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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
Exclusion criteria: Patients with no planned operation Contraindications against general anaesthesia Confessed allergy against propofol Patients under 18 years Pregnant women ASA-Classification 4 heavy respiratory disease anxiety disorder or other psychological disorder intake of analgetics 24 hours before studie starts amblyopia intake of anxiolytika before operation hypakusis insufficient knowledge of german language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the possibility of pain self assessment as a function of the sedation level. The main outcome variable will be: The error rate of the pain self assessment using the VAS as a function of sedation. ;Secondary Objective: To study until which sedation level the pain scales are applicable. To study which of the three used pain scales (VAS, verbal NRS and VDS) allows the best application in dependence of sedation.;Primary end point(s): Error rate of visual analog scale | — |
Countries
Austria
Outcome results
None listed