Dezocine for Prevention of Catheter-related Bladder Discomfort

Phase 4

Completed

• Conditions: Catheter Related Bladder Discomfort
• Interventions: Drug: Dezocine; Drug: Flurbiprofen Axetil

• Registration Number: NCT03147066
• Lead Sponsor: Jian-jun Yang

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Status Verified: 2017-08
• Study Start: 2017-09-01
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dezocine	Dezocine	0.1 mg/kg of intravenous dezocine 30 min before the end of surgery
Flurbiprofen axetil	Flurbiprofen Axetil	1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China