EUCTR2012-004585-18-DEActive, not recruitingPhase 1
Perioperative administration of Tapentadol – tolerance, safety and effects on postoperative rehabilitation and quality of life. Randomized, controlled study to compare the analgesic therapy with tapentadol compared to pure opioid receptor agonists - PATENT - Perioperative Administration of TapENTadol
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Philipps-Universität Marburg
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Woman who undergo abdominal or laparoscopic assisted hysterectomy, or men who undergo radical prostataectomy, as well as woman or men who undergo nephrectomy
- •2. elective surgery
- •3. ASA 1-3
- •4. at least 18 years old
- •5.negative pregnancy test (nephrectomy in women of childbearing age)
- •6. capacity
- •7. Existence of a written informed consent of the patient
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •1. Participation in other interventional trials,
- •2. Contraindications according to prescribing information
- •- paralytic ileus
- •- anamnese to a serotonery syndrom
- •- acute intoxication with alcohol, centrally acting analgesics or psychotropic substances
- •3. systemic opioid maintenance therapy within the last 4 weeks
- •4. Clinically significant hepatic and / or renal failure
- •5. Intolerance to one of the other drugs used in the study (propofol, fentanyl, remifentanil, morphine, rocuronium, etoricoxib)
- •6. cognitive disability or language barriers that impede adequate communication with the patient
- •7. People who are in a dependency / employment with the sponsor or investigator
Investigators
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