MedPath

The Efficacy of Intravenous Fixed Dosed Acetaminophen-Ibuprofen Combination Drug for Postoperative Catheter-Related Bladder Discomfort in Male Patients Undergoing Robot Assisted Laparoscopic Prostatectomy: Randomized, Double Blind, Placebo Control Studies

Not Applicable
Recruiting
Conditions
Neoplasms
Registration Number
KCT0007971
Lead Sponsor
Asan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
174
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

1) Conversion robot operation to open
2) Overactive bladder, neurogenic bladder
3) Morbid obesity
4) Uncontrolled hypertension, Ejection fraction < 40%, Arrhythmia requiring treatment, Unstable coronary artery disease
5) Patients with decreased renal function (Estimated glomerular filtration rate < 60 ml/min)
6) History of intracranial hemorrhage
7) History of Gastrointestinal ulcer, perforation, hemorrhage
8) Coagulopathy, Bleeding diasthesis, Wafarin or heparin administration
9) ALT (alanine aminotransferase)> 40 IU/L
10) AST (aspartate aminotransferase) > 40 IU/L
11) Patients taking Probenecide or lithium or Pentoxifylline or diuretics
12) Patients taking other non-staeroidal anti-inflammatory drugs
13) History of asthma, nasal polyp, angioedema, bronchospasm
14) Patients taking chronic analgesics medication
15) History of psychiatric disorder
16) Refusal of patient

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of moderate CRBD
Secondary Outcome Measures
NameTimeMethod
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
© Copyright 2025. All Rights Reserved by MedPath