EUCTR2009-016641-26-DE
Active, not recruiting
Phase 1
The influence of propofol and inhalational anesthetics on postoperative pain perception - QST and anesthetics
ZARI - Univeristätsmedizin Göttingen0 sites60 target enrollmentApril 22, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ZARI - Univeristätsmedizin Göttingen
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written informed consent obtained prior to study entry including informed consent for genetic research
- •2\.Both genders (male and female)
- •3\.Healthy adults aged \=18 to \< 65 years
- •4\.Body weight 50 – 100 kg and BMI 18 – 28 kg/m²
- •5\.Willingness to meet the study instructions and to co\-operate with the study personell.
- •6\.Female subjects will only be included if they have negative serum pregnancy test immediately before the general anesthesia.
- •7\. Patients with ASA I or II classification who undergo elective surgery with planned surgical time of up to 150 minutes and minimal to moderate surgical trauma.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\.Involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department)
- •2\.Participation in a clinical study during the last 30 days or use of any other investigational or non\-registered drug or vaccine during the study period or within 30 days preceding the first dose of study drugs
- •3\.Age \< 18 years or \> 65 years
- •4\.Any relevant clinical pathological which might affect the study measurements or pharmacokinetics or pharmacodynamics of the tested substances.
- •5\.Any disease affecting central or peripheral nerve system.
- •6\.Any disease in which use of the investigational medicinal products might be contraindicated.
- •7\.Any acute inflammatory disease
Outcomes
Primary Outcomes
Not specified
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