female patients in need of getting an abdominal hysterectomy due to an illness MedDRA version: 9.1 Level: LLT Classification code 10000075 Term: Abdominal hysterectomy
Conditions
Sponsors
Dr. Franz Köhler Chemie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: female with minimal age of 18 years need to undergo abdominal hyterectomy under general anesthesia written informed consent given 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • mechanical obstipation • mechanical urinary retention • gangrene • dystophia myotonica • depolarization block after application of depolarizing muscle relaxant • intoxication by depolarizing muscle relaxant of the Suxamethonium type • intoxication by irreversible acting cholinesterase inhibitors • enclosed craniocerebral injury • obstruction of the gastrointestinal tract and the revulsive urinary tract • current known allergic asthma bronchial or hostory of allergic asthma bronchiale • current serious diseases according ASA score > II esp. cardio- or cerebral vascular or pulmonary diseases • incapability of giving informed consent • current regular analgesic intake (opioids WHO III or NSAID/non-opioids for > 15 days/months or daily intake for the 7 last days) • Anaphylaxis on the active component or any athor component of Anticholium, Physostigminsalicylat (Ph.EUR.), Natriummetabisulfat (Ph.EUR.), placebo, Dipidolor, Metamizol or any other component of the IMP • Any surgery with persitent complaints within the last 2 months (exemption conization) • Recent history (6 months) or current evidence of alcohol or drug abuse; • Participation iin any other investigational drug therapy study within the last 90 days • Breastfeeding women • Body weight above 130 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: postoperativ opioid consumption via patient controlled analgesia (PCA) through 24 h;Secondary Objective: strength of resting pain (numerical rating scale) strenght of coughing pain (numerical rating scale) strength of pain under load (numerical rating scale) Symptom Distress Scale (SDS) patient's satisfaction with pain therapy patient's satisfaction with perioperative course rating of pain therapy by physician and nursing staff german version Gastrointestinal Quality of Life Index (GiQLI) quality of Life via Short-Form 36 (SF-36) transcutaneous oxygen nightly apnoe ECG point in time of first getting up days of incapacity of work resp. homework duration of PCA therapy ;Primary end point(s): consumption of morphin via PCA | — |
Countries
Germany
Outcome results
None listed