Dexmedetomidine for Catheter-related Bladder Discomfort
CRBDEX
Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort
2 other identifiers
interventional
114
1 country
1
Brief Summary
To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Nov 2013
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
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMarch 19, 2014
March 1, 2014
1 year
November 18, 2013
March 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The number of patients with catheter-related bladder discomfort
catheter-related bladder discomfort at postoperative 1 hour was evaluated as none, mild, moderate, severe. The number of patients with mild, moderate, severe discomfort will be calculated and compared between groups.
at postoperative 1 hour
Secondary Outcomes (2)
Catheter-related bladder discomfort
at postoperative 0, 1, 6, 24 hours
Pain at suprapubic area
at postoperative 0, 1, 6, 24 hours
Study Arms (2)
Placebo group
PLACEBO COMPARATORNS infusion will be done during surgery.
Dex group
EXPERIMENTALDEX infusion will be done during surgery.
Interventions
Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)
Eligibility Criteria
You may qualify if:
- Patients scheduled for transurethral bladder resection
- ASA I-III
You may not qualify if:
- Patient who disagrees to participate this investigation
- Patient with severe cardiovascular disease
- Patient with small-sized foley catheter (less than 18 Fr.)
- Patinets with any urinary tract obstructions
- Patient with hyperactive or neurogenic bladder
- Patients with chronic renal failure
- Patient with morbidly obese
- Patients with neurogenic disorder
- Patient with medications for chronic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.
PMID: 25485879DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Pyoung Park
Seoul National University of Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 25, 2013
Study Start
November 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
March 19, 2014
Record last verified: 2014-03