Dezocine for Prevention of Catheter-related Bladder Discomfort

Study Overview
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Brief Summary
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This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).

Detailed Description
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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.

Official Title
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Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort

Conditions
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Catheter Related Bladder Discomfort

Intervention / Treatment
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* Drug: Dezocine
* Drug: Flurbiprofen Axetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>/=18) Male or female Patients scheduled for abdominal surgery Undergoing catheterization Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2 Exclusion Criteria: Patient with bladder outflow obstruction Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h) Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases) Patient with chemical substance abuse Patient with chronic pain Patient with morbid obesity Patient needs for urgent intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dezocine<br>0.1 mg/kg of intravenous dezocine 30 min before the end of surgery | Drug: Dezocine<br>* Dezocine (0.1 mg/kg）will be infused during surgery<br>* Other names: Dalgan;|
| Active Comparator: Flurbiprofen axetil<br>1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery | Drug: Flurbiprofen Axetil<br>* Flurbiprofen Axetil (1 mg/kg）will be infused during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter related bladder discomfort symptoms | 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) | at 1 hour after extubatio | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter related bladder discomfort symptoms | 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) | at 0, 1, 2, and 6 hours after extubation | 
| Severity of pain at suprapubic area | Pain at suprapubic area will be evaluated using VAS after extubation | at 0, 1, 2, and 6 hours after extubation | 
| Sedation level | The Ramsay Sedation Scale was measured | at 0, 1, 2, and 6 hours after extubation | 
| Incidence of treatment-emergent adverse events | The incidence of nausea, vomiting, hypotension, hypertension, bradycardia,respiratory depression after extubation, and excessive sedation were also recorded | at 0, 1, 2, and 6 hours after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dezocine, CRBD, General anesthesia, Urinary catheter