Dezocine for Prevention of Catheter-related Bladder Discomfort
Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort
1 other identifier
interventional
96
1 country
1
Brief Summary
This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedOctober 31, 2017
August 1, 2017
2 months
May 2, 2017
October 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Catheter related bladder discomfort symptoms
at 0, 1, 2, and 6 hours after extubation
Severity of pain at suprapubic area
at 0, 1, 2, and 6 hours after extubation
Sedation level
at 0, 1, 2, and 6 hours after extubation
Incidence of treatment-emergent adverse events
at 0, 1, 2, and 6 hours after extubation
Study Arms (2)
Dezocine
EXPERIMENTAL0.1 mg/kg of intravenous dezocine 30 min before the end of surgery
Flurbiprofen axetil
ACTIVE COMPARATOR1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery
Interventions
Flurbiprofen Axetil (1 mg/kg）will be infused during surgery
Eligibility Criteria
You may qualify if:
- Adult (\>/=18)
- Male or female
- Patients scheduled for abdominal surgery
- Undergoing catheterization
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jian-jun Yanglead
Study Sites (1)
Zhongda Hospital
Nanjing, Jiangsu, 210009, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-jun Yang, PhD
Zhongda Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Department of Anesthesiology
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 10, 2017
Study Start
September 1, 2017
Primary Completion
October 30, 2017
Study Completion
October 30, 2017
Last Updated
October 31, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share