DRKS00005432CompletedPhase 3
Perioperative administration of Tapentadol – tolerance, safety and effectson postoperative recovery and quality of life.(PATENT)Randomized, controlled study to compare the analgesic therapy withtapentadol compared to pure opioid receptor agonists - PATENT
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Philipps-Universität Marburg
- Enrollment
- 121
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- Female
Inclusion Criteria
- •1. Woman who undergo abdominal or laparoscopic assisted
- •hysterectomy
- •2. elective surgery
- •3. ASA 1-3
- •4. not less than 18 jears old
- •5. capacity
- •6. Existence of a written informed consent of the subjects
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. Participation in another clinical trial, that affects the conduct of this study
Investigators
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