None listed
Conditions
Interventions
Drug : 1. Group M: Maxigesic (acetaminophen 1000mg/ibuprofen 300mg, 100ml, IV )
2. Group A: Active controlled group acetaminophen 1000mg (Acetphen premix 1g, 100ml, IV)
3. Group C: Placebo group:
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) male patients are scheduled to receive elective robot-assisted laparoscopic prostatectomy under general anesthesia 2) 20 = age < 80 3) Patients who voluntarily agree this clinical study 4) American society of Anesthesiologists physical status: 1-3 5) body weight = 50 kg
Exclusion criteria
Exclusion criteria: 1) Conversion robot operation to open 2) Overactive bladder, neurogenic bladder 3) Morbid obesity 4) Uncontrolled hypertension 5) Ejection fraction 1.6 mg/dl 8) Risk of renal failure because of hypovolemia or dehydration 9) History of intracranial hemorrhage 10) History of seizure, epilepsy, or risk of stroke 11) Gastrointestinal ulcer, perforation, bleeding 12) Hematologic problem, coagulopathy, bleeding diasthesis, oral anticoagulants, heparin administration ; cases withholding oral anticoagulants for 2-5 days before surgery is permitted. 13) Impaired hepatic function: AST, ALT > 40 IU/L 14) Administration of other NSAID 15) history of allergy, anaphylaxis, other side effects to acetaminophen, propacetamol, and aspirin, NSAIDs including COX-2 inhibitor 16) low dose aspirin for prevention for myocardial infartion or cerebral stroke: Antiplatelet drugs taken for preventive purposes are generally discontinued for at least 5 days before admission to the operating room, so patients can be included in the study unless they are taking aspirin continuously 17) Aspirin asthma, nasal polyp, angioedema, bronchospasm 18) Hypersensitivity for acetaminophen, propacetamol, ibuprofen 19) chronic analgesics medication 20) Interaction with acetaminophen or ibuprofen: barbiturates, tricyclic antidepressants, long term use of corticosteroid or warfarin, probenecid, Salicylamide, enzyme induceing agents (isoniazid, carbamazepine, phenobarbital, rifampicin, primidone, zidovudin), phenytoin, busulfan, chloramphenicol, diflunisal, cyclosporin, tacrolimus, seletive-serotonin reuptake inhibitor, mifepristone, lithium, qunolon antibiotics, 21) alcohol abuse 22) Glucose-6-phosphate dehydrogenase deficiency 23) anorexia, bulimia or cachexia (low reserves of hepatic glutathione) 24) Systemic lupus erythematosus and related connective tissue disease 25) Ulcerative colitis, Crohn's disease 26) patients with spinal cord injuries 27) Psyciatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate CRBD | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of moderate CRBD and postoperative pain score ;amount of analgesics ;Drug related postoperative complication and the incidence of nausea/vomiting ;The Korean version of Quality of Recovery-15, QoR15K | — |
Countries
Korea, Republic of
Contacts
Public ContactHeesun Park
Asan Medical Center
Outcome results
None listed