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Clinical Trials/EUCTR2010-024201-12-AT
EUCTR2010-024201-12-AT
Active, not recruiting
Phase 1

Klinische Pilotstudie Zum Prospektiven Vergleich der Analgetischen Wirksamkeit Eines Oralen Und Eines Invasiven Opiat-Regimes Nach Herzchirurgischen Operationen - Targin

Med. Uni. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie0 sites86 target enrollmentJune 27, 2011
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DrugsTARGIN retard 10 mgVendal

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Med. Uni. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Enrollment
86
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 27, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Med. Uni. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Eligibility Criteria

Inclusion Criteria

  • •â€¢Age from 18 to 90 years
  • •â€¢ASA physical status 1\-3
  • •â€¢Elective major cardiac surgery requiring sternotomy
  • •â€¢Oral and written consent
  • •â€¢Postoperative extubation within four hours after arrival at the ICU
  • •â€¢Cognitive ability in the use of the PCA pump and the VAS
  • •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

Exclusion Criteria

  • •1\.Chronic use of opiods in the last three months
  • •2\.Chronic use of tranquilizer or pain medications
  • •3\.Hypersensitivity against opiods
  • •4\.Use of monoamine oxidase inhibitors in the last two weeks before surgery
  • •5\.Alcohol or drug abuse
  • •6\.Renal dysfunction (GFR \< 30 or necessity of dialysis)
  • •7\.Liver Dysfunction defined as Child\-Pugh\-Score 7\-15
  • •8\.Ejection fraction (EF\< 40%)
  • •9\.Malabsorption syndrome
  • •10\.Neurologic or cognitive dysfunction

Outcomes

Primary Outcomes

Not specified

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