Catheter Related Bladder Discomfort
Conditions
Keywords
Dezocine, CRBD, General anesthesia, Urinary catheter
Brief summary
This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).
Detailed description
Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
Interventions
DRUGDezocine
Dezocine (0.1 mg/kg）will be infused during surgery
Flurbiprofen Axetil (1 mg/kg）will be infused during surgery
Sponsors
Jian-jun Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult (\>/=18) 2. Male or female 3. Patients scheduled for abdominal surgery 4. Undergoing catheterization 5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2
Exclusion criteria
1. Patient with bladder outflow obstruction 2. Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h) 3. Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases) 4. Patient with chemical substance abuse 5. Patient with chronic pain 6. Patient with morbid obesity 7. Patient needs for urgent intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter related bladder discomfort symptoms | at 1 hour after extubatio | CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter related bladder discomfort symptoms | at 0, 1, 2, and 6 hours after extubation | CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) |
| Severity of pain at suprapubic area | at 0, 1, 2, and 6 hours after extubation | Pain at suprapubic area will be evaluated using VAS after extubation |
| Sedation level | at 0, 1, 2, and 6 hours after extubation | The Ramsay Sedation Scale was measured |
| Incidence of treatment-emergent adverse events | at 0, 1, 2, and 6 hours after extubation | The incidence of nausea, vomiting, hypotension, hypertension, bradycardia,respiratory depression after extubation, and excessive sedation were also recorded |
Countries
China
Outcome results
None listed