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Clinical Trials/EUCTR2009-016641-26-DE
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.

Registry
who.int
Start Date
April 22, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ZARI - Univeristätsmedizin Göttingen

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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